FDA 21 CFR Part 892 Radiology Devices

FDA 21 CFR Part 892 Radiology Devices:

FDA 21 CFR Part 892 Radiology Devices: (a) This part sets forth the classification of radiology devices intended for human use that are in commercial distribution.

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Table of contents

Subpart A - General Provisions

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).

Subpart B - Diagnostic Devices

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 Medical image management and processing 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.

Subparts C-E [Reserved]

Subpart F - Therapeutic Devices

892.5050 Medical charged-particle 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.

892.5730 Radionuclide brachytherapy source.

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.

892.5840 Radiation therapy simulation system.

892.5900 X-ray radiation therapy system.

892.5930 Therapeutic x-ray tube housing assembly.

Subpart G - Miscellaneous Devices

892.6500 Personnel protective shield.

FDA 21 CFR Part 892 Radiology Devices:

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