';


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 August 20, 2019

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.

return arrow Back to Top

§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.

[53 FR 5078, Feb. 1, 1989]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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. 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 §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001]

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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.

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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.

[55 FR 48444, Nov. 20, 1990]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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]

return arrow Back to Top

§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.).

[63 FR 23387, Apr. 29, 1998]

return arrow Back to Top

§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).

[63 FR 23387, Apr. 29, 1998]

return arrow Back to Top

§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]

return arrow Back to Top