Subpart B—Diagnostic Devices

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• § 892.1000
  § 892.1000 Magnetic resonance diagnostic device.
• § 892.1001
  § 892.1001 Liver iron concentration imaging companion diagnostic for deferasirox.
• § 892.1100
  § 892.1100 Scintillation (gamma) camera.
• § 892.1110
  § 892.1110 Positron camera.
• § 892.1130
  § 892.1130 Nuclear whole body counter.
• § 892.1170
  § 892.1170 Bone densitometer.
• § 892.1180
  § 892.1180 Bone sonometer.
• § 892.1200
  § 892.1200 Emission computed tomography system.
• § 892.1220
  § 892.1220 Fluorescent scanner.
• § 892.1300
  § 892.1300 Nuclear rectilinear scanner.
• § 892.1310
  § 892.1310 Nuclear tomography system.
• § 892.1320
  § 892.1320 Nuclear uptake probe.
• § 892.1330
  § 892.1330 Nuclear whole body scanner.
• § 892.1350
  § 892.1350 Nuclear scanning bed.
• § 892.1360
  § 892.1360 Radionuclide dose calibrator.
• § 892.1370
  § 892.1370 Nuclear anthropomorphic phantom.
• § 892.1380
  § 892.1380 Nuclear flood source phantom.
• § 892.1390
  § 892.1390 Radionuclide rebreathing system.
• § 892.1400
  § 892.1400 Nuclear sealed calibration source.
• § 892.1410
  § 892.1410 Nuclear electrocardiograph synchronizer.
• § 892.1420
  § 892.1420 Radionuclide test pattern phantom.
• § 892.1540
  § 892.1540 Nonfetal ultrasonic monitor.
• § 892.1550
  § 892.1550 Ultrasonic pulsed doppler imaging system.
• § 892.1560
  § 892.1560 Ultrasonic pulsed echo imaging system.
• § 892.1570
  § 892.1570 Diagnostic ultrasonic transducer.
• § 892.1600
  § 892.1600 Angiographic x-ray system.
• § 892.1610
  § 892.1610 Diagnostic x-ray beam-limiting device.
• § 892.1620
  § 892.1620 Cine or spot fluorographic x-ray camera.
• § 892.1630
  § 892.1630 Electrostatic x-ray imaging system.
• § 892.1640
  § 892.1640 Radiographic film marking system.
• § 892.1650
  § 892.1650 Image-intensified fluoroscopic x-ray system.
• § 892.1660
  § 892.1660 Non-image-intensified fluoroscopic x-ray system.
• § 892.1670
  § 892.1670 Spot-film device.
• § 892.1680
  § 892.1680 Stationary x-ray system.
• § 892.1700
  § 892.1700 Diagnostic x-ray high voltage generator.
• § 892.1710
  § 892.1710 Mammographic x-ray system.
• § 892.1715
  § 892.1715 Full-field digital mammography system.
• § 892.1720
  § 892.1720 Mobile x-ray system.
• § 892.1730
  § 892.1730 Photofluorographic x-ray system.
• § 892.1740
  § 892.1740 Tomographic x-ray system.
• § 892.1750
  § 892.1750 Computed tomography x-ray system.
• § 892.1760
  § 892.1760 Diagnostic x-ray tube housing assembly.
• § 892.1770
  § 892.1770 Diagnostic x-ray tube mount.
• § 892.1820
  § 892.1820 Pneumoencephalographic chair.
• § 892.1830
  § 892.1830 Radiologic patient cradle.
• § 892.1840
  § 892.1840 Radiographic film.
• § 892.1850
  § 892.1850 Radiographic film cassette.
• § 892.1860
  § 892.1860 Radiographic film/cassette changer.
• § 892.1870
  § 892.1870 Radiographic film/cassette changer programmer.
• § 892.1880
  § 892.1880 Wall-mounted radiographic cassette holder.
• § 892.1890
  § 892.1890 Radiographic film illuminator.
• § 892.1900
  § 892.1900 Automatic radiographic film processor.
• § 892.1910
  § 892.1910 Radiographic grid.
• § 892.1920
  § 892.1920 Radiographic head holder.
• § 892.1940
  § 892.1940 Radiologic quality assurance instrument.
• § 892.1950
  § 892.1950 Radiographic anthropomorphic phantom.
• § 892.1960
  § 892.1960 Radiographic intensifying screen.
• § 892.1970
  § 892.1970 Radiographic ECG/respirator synchronizer.
• § 892.1980
  § 892.1980 Radiologic table.
• § 892.1990
  § 892.1990 Transilluminator for breast evaluation.
• § 892.2010
  § 892.2010 Medical image storage device.
• § 892.2020
  § 892.2020 Medical image communications device.
• § 892.2030
  § 892.2030 Medical image digitizer.
• § 892.2040
  § 892.2040 Medical image hardcopy device.
• § 892.2050
  § 892.2050 Medical image management and processing system.
• § 892.2055
  § 892.2055 Radiological machine learning-based quantitative imaging software with predetermined change control plan.
• § 892.2060
  § 892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
• § 892.2070
  § 892.2070 Medical image analyzer.
• § 892.2080
  § 892.2080 Radiological computer aided triage and notification software.
• § 892.2090
  § 892.2090 Radiological computer-assisted detection and diagnosis software.
• 892.2100
  892.2100 Radiological acquisition and/or optimization guidance system.