Part 892 — Radiology Devices
Current through Sep 8, 2026
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
Editorial Note: Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.
Sections
- § 892.1 Scope.
- § 892.3 Effective dates of requirement for premarket approval.
- § 892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- § 892.1000 Magnetic resonance diagnostic device.
- § 892.1001 Liver iron concentration imaging companion diagnostic for deferasirox.
- § 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 Medical image management and processing system.
- § 892.2055 Radiological machine learning-based quantitative imaging software with predetermined change control plan.
- § 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.
- § 892.2090 Radiological computer-assisted detection and diagnosis software.
- 892.2100 Radiological acquisition and/or optimization guidance system.
- § 892.5050 Medical charged-particle radiation therapy system.
- § 892.5060 Fludeoxyglucose F18-guided radiation therapy system.
- § 892.5300 Medical neutron radiation therapy system.
- § 892.5650 Manual radionuclide applicator system.
- § 892.5700 Remote controlled radionuclide applicator system.
- § 892.5710 Radiation therapy beam-shaping block.
- § 892.5720 Rectal balloon for prostate immobilization.
- § 892.5725 Absorbable perirectal spacer.
- § 892.5727 Phase-changing fiducial marker for radiation therapy.
- § 892.5730 Radionuclide brachytherapy source.
- § 892.5735 Vaginal hydrogel packing system.
- § 892.5740 Radionuclide teletherapy source.
- § 892.5750 Radionuclide radiation therapy system.
- § 892.5770 Powered radiation therapy patient support assembly.
- § 892.5780 Light beam patient position indicator.
- § 892.5785 Radiation therapy marking device.
- § 892.5840 Radiation therapy simulation system.
- § 892.5900 X-ray radiation therapy system.
- § 892.5930 Therapeutic x-ray tube housing assembly.
- § 892.6500 Personnel protective shield.
- § 892.6510 Cream for x-ray attenuation.