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Title 21 - Title 21
Part 892 - RADIOLOGY DEVICES
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Details about Part 892
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MEDICAL DEVICES - RADIOLOGY DEVICES
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83 sections
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§892.1 - Scope.
Title 21, Part 892
§892.1000 - Magnetic resonance diagnostic device.
Title 21, Part 892
§892.1100 - Scintillation (gamma) camera.
Title 21, Part 892
§892.1110 - Positron camera.
Title 21, Part 892
§892.1130 - Nuclear whole body counter.
Title 21, Part 892
§892.1170 - Bone densitometer.
Title 21, Part 892
§892.1180 - Bone sonometer.
Title 21, Part 892
§892.1200 - Emission computed tomography system.
Title 21, Part 892
§892.1220 - Fluorescent scanner.
Title 21, Part 892
§892.1300 - Nuclear rectilinear scanner.
Title 21, Part 892
§892.1310 - Nuclear tomography system.
Title 21, Part 892
§892.1320 - Nuclear uptake probe.
Title 21, Part 892
§892.1330 - Nuclear whole body scanner.
Title 21, Part 892
§892.1350 - Nuclear scanning bed.
Title 21, Part 892
§892.1360 - Radionuclide dose calibrator.
Title 21, Part 892
§892.1370 - Nuclear anthropomorphic phantom.
Title 21, Part 892
§892.1380 - Nuclear flood source phantom.
Title 21, Part 892
§892.1390 - Radionuclide rebreathing system.
Title 21, Part 892
§892.1400 - Nuclear sealed calibration source.
Title 21, Part 892
§892.1410 - Nuclear electrocardiograph synchronizer.
Title 21, Part 892
§892.1420 - Radionuclide test pattern phantom.
Title 21, Part 892
§892.1540 - Nonfetal ultrasonic monitor.
Title 21, Part 892
§892.1550 - Ultrasonic pulsed doppler imaging system.
Title 21, Part 892
§892.1560 - Ultrasonic pulsed echo imaging system.
Title 21, Part 892
§892.1570 - Diagnostic ultrasonic transducer.
Title 21, Part 892
§892.1600 - Angiographic x-ray system.
Title 21, Part 892
§892.1610 - Diagnostic x-ray beam-limiting device.
Title 21, Part 892
§892.1620 - Cine or spot fluorographic x-ray camera.
Title 21, Part 892
§892.1630 - Electrostatic x-ray imaging system.
Title 21, Part 892
§892.1640 - Radiographic film marking system.
Title 21, Part 892
§892.1650 - Image-intensified fluoroscopic x-ray system.
Title 21, Part 892
§892.1660 - Non-image-intensified fluoroscopic x-ray system.
Title 21, Part 892
§892.1670 - Spot-film device.
Title 21, Part 892
§892.1680 - Stationary x-ray system.
Title 21, Part 892
§892.1700 - Diagnostic x-ray high voltage generator.
Title 21, Part 892
§892.1710 - Mammographic x-ray system.
Title 21, Part 892
§892.1715 - Full-field digital mammography system.
Title 21, Part 892
§892.1720 - Mobile x-ray system.
Title 21, Part 892
§892.1730 - Photofluorographic x-ray system.
Title 21, Part 892
§892.1740 - Tomographic x-ray system.
Title 21, Part 892
§892.1750 - Computed tomography x-ray system.
Title 21, Part 892
§892.1760 - Diagnostic x-ray tube housing assembly.
Title 21, Part 892
§892.1770 - Diagnostic x-ray tube mount.
Title 21, Part 892
§892.1820 - Pneumoencephalographic chair.
Title 21, Part 892
§892.1830 - Radiologic patient cradle.
Title 21, Part 892
§892.1840 - Radiographic film.
Title 21, Part 892
§892.1850 - Radiographic film cassette.
Title 21, Part 892
§892.1860 - Radiographic film/cassette changer.
Title 21, Part 892
§892.1870 - Radiographic film/cassette changer programmer.
Title 21, Part 892
§892.1880 - Wall-mounted radiographic cassette holder.
Title 21, Part 892
§892.1890 - Radiographic film illuminator.
Title 21, Part 892
§892.1900 - Automatic radiographic film processor.
Title 21, Part 892
§892.1910 - Radiographic grid.
Title 21, Part 892
§892.1920 - Radiographic head holder.
Title 21, Part 892
§892.1940 - Radiologic quality assurance instrument.
Title 21, Part 892
§892.1950 - Radiographic anthropomorphic phantom.
Title 21, Part 892
§892.1960 - Radiographic intensifying screen.
Title 21, Part 892
§892.1970 - Radiographic ECG/respirator synchronizer.
Title 21, Part 892
§892.1980 - Radiologic table.
Title 21, Part 892
§892.1990 - Transilluminator for breast evaluation.
Title 21, Part 892
§892.2010 - Medical image storage device.
Title 21, Part 892
§892.2020 - Medical image communications device.
Title 21, Part 892
§892.2030 - Medical image digitizer.
Title 21, Part 892
§892.2040 - Medical image hardcopy device.
Title 21, Part 892
§892.2050 - Picture archiving and communications system.
Title 21, Part 892
§892.3 - Effective dates of requirement for premarket approval.
Title 21, Part 892
§892.5050 - Medical charged-particle radiation therapy system.
Title 21, Part 892
§892.5300 - Medical neutron radiation therapy system.
Title 21, Part 892
§892.5650 - Manual radionuclide applicator system.
Title 21, Part 892
§892.5700 - Remote controlled radionuclide applicator system.
Title 21, Part 892
§892.5710 - Radiation therapy beam-shaping block.
Title 21, Part 892
§892.5720 - Rectal balloon for prostate immobilization.
Title 21, Part 892
§892.5725 - Absorbable perirectal spacer.
Title 21, Part 892
§892.5730 - Radionuclide brachytherapy source.
Title 21, Part 892
§892.5740 - Radionuclide teletherapy source.
Title 21, Part 892
§892.5750 - Radionuclide radiation therapy system.
Title 21, Part 892
§892.5770 - Powered radiation therapy patient support assembly.
Title 21, Part 892
§892.5780 - Light beam patient position indicator.
Title 21, Part 892
§892.5840 - Radiation therapy simulation system.
Title 21, Part 892
§892.5900 - X-ray radiation therapy system.
Title 21, Part 892
§892.5930 - Therapeutic x-ray tube housing assembly.
Title 21, Part 892
§892.6500 - Personnel protective shield.
Title 21, Part 892
§892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Title 21, Part 892