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Title 21 Part 892 → Subpart B

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B

e-CFR data is current as of May 26, 2020

Title 21Chapter ISubchapter HPart 892 → Subpart B


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES


Subpart B—Diagnostic Devices


Contents
§892.1000   Magnetic resonance diagnostic device.
§892.1100   Scintillation (gamma) camera.
§892.1110   Positron camera.
§892.1130   Nuclear whole body counter.
§892.1170   Bone densitometer.
§892.1180   Bone sonometer.
§892.1200   Emission computed tomography system.
§892.1220   Fluorescent scanner.
§892.1300   Nuclear rectilinear scanner.
§892.1310   Nuclear tomography system.
§892.1320   Nuclear uptake probe.
§892.1330   Nuclear whole body scanner.
§892.1350   Nuclear scanning bed.
§892.1360   Radionuclide dose calibrator.
§892.1370   Nuclear anthropomorphic phantom.
§892.1380   Nuclear flood source phantom.
§892.1390   Radionuclide rebreathing system.
§892.1400   Nuclear sealed calibration source.
§892.1410   Nuclear electrocardiograph synchronizer.
§892.1420   Radionuclide test pattern phantom.
§892.1540   Nonfetal ultrasonic monitor.
§892.1550   Ultrasonic pulsed doppler imaging system.
§892.1560   Ultrasonic pulsed echo imaging system.
§892.1570   Diagnostic ultrasonic transducer.
§892.1600   Angiographic x-ray system.
§892.1610   Diagnostic x-ray beam-limiting device.
§892.1620   Cine or spot fluorographic x-ray camera.
§892.1630   Electrostatic x-ray imaging system.
§892.1640   Radiographic film marking system.
§892.1650   Image-intensified fluoroscopic x-ray system.
§892.1660   Non-image-intensified fluoroscopic x-ray system.
§892.1670   Spot-film device.
§892.1680   Stationary x-ray system.
§892.1700   Diagnostic x-ray high voltage generator.
§892.1710   Mammographic x-ray system.
§892.1715   Full-field digital mammography system.
§892.1720   Mobile x-ray system.
§892.1730   Photofluorographic x-ray system.
§892.1740   Tomographic x-ray system.
§892.1750   Computed tomography x-ray system.
§892.1760   Diagnostic x-ray tube housing assembly.
§892.1770   Diagnostic x-ray tube mount.
§892.1820   Pneumoencephalographic chair.
§892.1830   Radiologic patient cradle.
§892.1840   Radiographic film.
§892.1850   Radiographic film cassette.
§892.1860   Radiographic film/cassette changer.
§892.1870   Radiographic film/cassette changer programmer.
§892.1880   Wall-mounted radiographic cassette holder.
§892.1890   Radiographic film illuminator.
§892.1900   Automatic radiographic film processor.
§892.1910   Radiographic grid.
§892.1920   Radiographic head holder.
§892.1940   Radiologic quality assurance instrument.
§892.1950   Radiographic anthropomorphic phantom.
§892.1960   Radiographic intensifying screen.
§892.1970   Radiographic ECG/respirator synchronizer.
§892.1980   Radiologic table.
§892.1990   Transilluminator for breast evaluation.
§892.2010   Medical image storage device.
§892.2020   Medical image communications device.
§892.2030   Medical image digitizer.
§892.2040   Medical image hardcopy device.
§892.2050   Picture archiving and communications system.
§892.2060   Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
§892.2070   Medical image analyzer.
§892.2080   Radiological computer aided triage and notification software.

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§892.1000   Magnetic resonance diagnostic device.

(a) Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

(b) Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[53 FR 5078, Feb. 1, 1989, as amended at 84 FR 71818, Dec. 30, 2019]

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§892.1100   Scintillation (gamma) camera.

(a) Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

(b) Classification. Class I (general controls).

[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]

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§892.1110   Positron camera.

(a) Identification. A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

(b) Classification. Class I (general controls).

[55 FR 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]

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§892.1130   Nuclear whole body counter.

(a) Identification. A nuclear whole body counter is a device intended to measure the amount of radionuclides in the entire body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38818, July 25, 2001]

[55 FR 48444, Nov. 20, 1990]

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§892.1170   Bone densitometer.

(a) Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1180   Bone sonometer.

(a) Identification. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See §892.1(e) for the availability of this guidance document.

[73 FR 40969, July 17, 2008]

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§892.1200   Emission computed tomography system.

(a) Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

(b) Classification. Class II.

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§892.1220   Fluorescent scanner.

(a) Identification. A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts and accessories.

(b) Classification. Class II.

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§892.1300   Nuclear rectilinear scanner.

(a) Identification. A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000; 66 FR 38818, July 25, 2001]

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§892.1310   Nuclear tomography system.

(a) Identification. A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

(b) Classification. Class II.

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§892.1320   Nuclear uptake probe.

(a) Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]

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§892.1330   Nuclear whole body scanner.

(a) Identification. A nuclear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide-aperture detector whose position moves in one direction with respect to the patient. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]

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§892.1350   Nuclear scanning bed.

(a) Identification. A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 65 FR 2322, Jan. 14, 2000]

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§892.1360   Radionuclide dose calibrator.

(a) Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.

(b) Classification. Class II.

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§892.1370   Nuclear anthropomorphic phantom.

(a) Identification. A nuclear anthropomorphic phantom is a human tissue facsimile that contains a radioactive source or a cavity in which a radioactive sample can be inserted. It is intended to calibrate nuclear uptake probes or other medical instruments.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38818, July 25, 2001]

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§892.1380   Nuclear flood source phantom.

(a) Identification. A nuclear flood source phantom is a device that consists of a radiolucent container filled with a uniformly distributed solution of a desired radionuclide. It is intended to calibrate a medical gamma camera-collimator system for uniformity of response.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, 2001]

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§892.1390   Radionuclide rebreathing system.

(a) Identification. A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1400   Nuclear sealed calibration source.

(a) Identification. A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, 2001]

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§892.1410   Nuclear electrocardiograph synchronizer.

(a) Identification. A nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]

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§892.1420   Radionuclide test pattern phantom.

(a) Identification. A radionuclide test pattern phantom is a device that consists of an arrangement of radiopaque or radioactive material sealed in a solid pattern intended to serve as a test for a performance characteristic of a nuclear medicine imaging device.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, 2001]

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§892.1540   Nonfetal ultrasonic monitor.

(a) Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1550   Ultrasonic pulsed doppler imaging system.

(a) Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1560   Ultrasonic pulsed echo imaging system.

(a) Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]

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§892.1570   Diagnostic ultrasonic transducer.

(a) Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

(b) Classification. Class II.

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§892.1600   Angiographic x-ray system.

(a) Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1610   Diagnostic x-ray beam-limiting device.

(a) Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]

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§892.1620   Cine or spot fluorographic x-ray camera.

(a) Identification. A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.

(b) Classification. Class II.

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§892.1630   Electrostatic x-ray imaging system.

(a) Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1640   Radiographic film marking system.

(a) Identification. A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]

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§892.1650   Image-intensified fluoroscopic x-ray system.

(a) Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001; 84 FR 71818, Dec. 30, 2019]

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§892.1660   Non-image-intensified fluoroscopic x-ray system.

(a) Identification. A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1670   Spot-film device.

(a) Identification. A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]

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§892.1680   Stationary x-ray system.

(a) Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]

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§892.1700   Diagnostic x-ray high voltage generator.

(a) Identification. A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. This generic type of device may include a converter that changes alternating current to direct current, filament transformers for the x-ray tube, high voltage switches, electrical protective devices, or other appropriate elements.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]

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§892.1710   Mammographic x-ray system.

(a) Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1715   Full-field digital mammography system.

(a) Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.” See §892.1(e) for the availability of this guidance document.

[75 FR 68203, Nov. 5, 2010]

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§892.1720   Mobile x-ray system.

(a) Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1730   Photofluorographic x-ray system.

(a) Identification. A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]

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§892.1740   Tomographic x-ray system.

(a) Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1750   Computed tomography x-ray system.

(a) Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

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§892.1760   Diagnostic x-ray tube housing assembly.

(a) Identification. A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]

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§892.1770   Diagnostic x-ray tube mount.

(a) Identification. A diagnostic x-ray tube mount is a device intended to support and to position the diagnostic x-ray tube housing assembly for a medical radiographic procedure.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]

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§892.1820   Pneumoencephalographic chair.

(a) Identification. A pneumoencephalographic chair is a chair intended to support and position a patient during pneumoencephalography (x-ray imaging of the brain).

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]

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§892.1830   Radiologic patient cradle.

(a) Identification. A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]

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§892.1840   Radiographic film.

(a) Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]

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§892.1850   Radiographic film cassette.

(a) Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]

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§892.1860   Radiographic film/cassette changer.

(a) Identification. A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]

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§892.1870   Radiographic film/cassette changer programmer.

(a) Identification. A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]

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§892.1880   Wall-mounted radiographic cassette holder.

(a) Identification. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]

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§892.1890   Radiographic film illuminator.

(a) Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000]

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§892.1900   Automatic radiographic film processor.

(a) Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 84 FR 71819, Dec. 30, 2019]

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§892.1910   Radiographic grid.

(a) Identification. A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]

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§892.1920   Radiographic head holder.

(a) Identification. A radiographic head holder is a device intended to position the patient's head during a radiographic procedure.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]

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§892.1940   Radiologic quality assurance instrument.

(a) Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]

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§892.1950   Radiographic anthropomorphic phantom.

(a) Identification. A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]

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§892.1960   Radiographic intensifying screen.

(a) Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]

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§892.1970   Radiographic ECG/respirator synchronizer.

(a) Identification. A radiographic ECG/respirator synchronizer is a device intended to be used to coordinate an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2323, Jan. 14, 2000]

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§892.1980   Radiologic table.

(a) Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 63 FR 59231, Nov. 3, 1998]

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§892.1990   Transilluminator for breast evaluation.

(a) Identification. A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensity emissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA by April 17, 2014, for any transilluminator for breast evaluation that was in commercial distribution before May 28, 1976, or that has, by April 17, 2014, been found to be substantially equivalent to any transilluminator for breast evaluation that was in commercial distribution before May 28, 1976. Any other transilluminator for breast evaluation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[60 FR 36639, July 18, 1995, as amended at 79 FR 3094, Jan. 17, 2014]

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§892.2010   Medical image storage device.

(a) Identification. A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 65 FR 2323, Jan. 14, 2000]

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§892.2020   Medical image communications device.

(a) Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.

[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 65 FR 2323, Jan. 14, 2000]

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§892.2030   Medical image digitizer.

(a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019]

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§892.2040   Medical image hardcopy device.

(a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[63 FR 23387, Apr. 29, 1998, as amended at 84 FR 71819, Dec. 30, 2019]

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§892.2050   Picture archiving and communications system.

(a) Identification. A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

[63 FR 23387, Apr. 29, 1998]

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§892.2060   Radiological computer-assisted diagnostic software for lesions suspicious of cancer.

(a) Identification. A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include:

(i) A detailed description of the image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, and algorithm limitations.

(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will improve reader performance as intended.

(iii) Results from performance testing protocols that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.

(iv) Standalone performance testing protocols and results of the device.

(v) Appropriate software documentation (e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; and description of verification and validation activities including system level test protocol, pass/fail criteria, results, and cybersecurity).

(2) Labeling must include:

(i) A detailed description of the patient population for which the device is indicated for use.

(ii) A detailed description of the intended reading protocol.

(iii) A detailed description of the intended user and recommended user training.

(iv) A detailed description of the device inputs and outputs.

(v) A detailed description of compatible imaging hardware and imaging protocols.

(vi) Warnings, precautions, and limitations, including situations in which the device may fail or may not operate at its expected performance level (e.g., poor image quality or for certain subpopulations), as applicable.

(vii) Detailed instructions for use.

(viii) A detailed summary of the performance testing, including: Test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders (e.g., lesion and organ characteristics, disease stages, and imaging equipment).

[85 FR 3542, Jan. 22, 2020]

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§892.2070   Medical image analyzer.

(a) Identification. Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, is a prescription device that is intended to identify, mark, highlight, or in any other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include:

(i) A detailed description of the image analysis algorithms including a description of the algorithm inputs and outputs, each major component or block, and algorithm limitations.

(ii) A detailed description of pre-specified performance testing methods and dataset(s) used to assess whether the device will improve reader performance as intended and to characterize the standalone device performance. Performance testing includes one or more standalone tests, side-by-side comparisons, or a reader study, as applicable.

(iii) Results from performance testing that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain a sufficient number of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.

(iv) Appropriate software documentation (e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results; and cybersecurity).

(2) Labeling must include the following:

(i) A detailed description of the patient population for which the device is indicated for use.

(ii) A detailed description of the intended reading protocol.

(iii) A detailed description of the intended user and user training that addresses appropriate reading protocols for the device.

(iv) A detailed description of the device inputs and outputs.

(v) A detailed description of compatible imaging hardware and imaging protocols.

(vi) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (e.g., poor image quality or for certain subpopulations), as applicable.

(vii) Device operating instructions.

(viii) A detailed summary of the performance testing, including: test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

[85 FR 3548, Jan. 22, 2020]

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§892.2080   Radiological computer aided triage and notification software.

(a) Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Design verification and validation must include:

(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.

(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (e.g., improved time to review of prioritized images for pre-specified clinicians).

(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.

(iv) Stand-alone performance testing protocols and results of the device.

(v) Appropriate software documentation (e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).

(2) Labeling must include the following:

(i) A detailed description of the patient population for which the device is indicated for use;

(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;

(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (e.g., poor image quality for certain subpopulations), as applicable;

(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;

(v) Device operating instructions; and

(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

[85 FR 3544, Jan. 22, 2020]

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