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FEDERAL · 21 CFR

Part 892 — Radiology Devices

90 sections · Title 21: Food and Drugs

§ 892.1Scope.
§ 892.3Effective dates of requirement for premarket approval.
§ 892.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 892.1000Magnetic resonance diagnostic device.
§ 892.1001Liver iron concentration imaging companion diagnostic for deferasirox.
§ 892.1100Scintillation (gamma) camera.
§ 892.1110Positron camera.
§ 892.1130Nuclear whole body counter.
§ 892.1170Bone densitometer.
§ 892.1180Bone sonometer.
§ 892.1200Emission computed tomography system.
§ 892.1220Fluorescent scanner.
§ 892.1300Nuclear rectilinear scanner.
§ 892.1310Nuclear tomography system.
§ 892.1320Nuclear uptake probe.
§ 892.1330Nuclear whole body scanner.
§ 892.1350Nuclear scanning bed.
§ 892.1360Radionuclide dose calibrator.
§ 892.1370Nuclear anthropomorphic phantom.
§ 892.1380Nuclear flood source phantom.
§ 892.1390Radionuclide rebreathing system.
§ 892.1400Nuclear sealed calibration source.
§ 892.1410Nuclear electrocardiograph synchronizer.
§ 892.1420Radionuclide test pattern phantom.
§ 892.1540Nonfetal ultrasonic monitor.
§ 892.1550Ultrasonic pulsed doppler imaging system.
§ 892.1560Ultrasonic pulsed echo imaging system.
§ 892.1570Diagnostic ultrasonic transducer.
§ 892.1600Angiographic x-ray system.
§ 892.1610Diagnostic x-ray beam-limiting device.
§ 892.1620Cine or spot fluorographic x-ray camera.
§ 892.1630Electrostatic x-ray imaging system.
§ 892.1640Radiographic film marking system.
§ 892.1650Image-intensified fluoroscopic x-ray system.
§ 892.1660Non-image-intensified fluoroscopic x-ray system.
§ 892.1670Spot-film device.
§ 892.1680Stationary x-ray system.
§ 892.1700Diagnostic x-ray high voltage generator.
§ 892.1710Mammographic x-ray system.
§ 892.1715Full-field digital mammography system.
§ 892.1720Mobile x-ray system.
§ 892.1730Photofluorographic x-ray system.
§ 892.1740Tomographic x-ray system.
§ 892.1750Computed tomography x-ray system.
§ 892.1760Diagnostic x-ray tube housing assembly.
§ 892.1770Diagnostic x-ray tube mount.
§ 892.1820Pneumoencephalographic chair.
§ 892.1830Radiologic patient cradle.
§ 892.1840Radiographic film.
§ 892.1850Radiographic film cassette.
§ 892.1860Radiographic film/cassette changer.
§ 892.1870Radiographic film/cassette changer programmer.
§ 892.1880Wall-mounted radiographic cassette holder.
§ 892.1890Radiographic film illuminator.
§ 892.1900Automatic radiographic film processor.
§ 892.1910Radiographic grid.
§ 892.1920Radiographic head holder.
§ 892.1940Radiologic quality assurance instrument.
§ 892.1950Radiographic anthropomorphic phantom.
§ 892.1960Radiographic intensifying screen.
§ 892.1970Radiographic ECG/respirator synchronizer.
§ 892.1980Radiologic table.
§ 892.1990Transilluminator for breast evaluation.
§ 892.2010Medical image storage device.
§ 892.2020Medical image communications device.
§ 892.2030Medical image digitizer.
§ 892.2040Medical image hardcopy device.
§ 892.2050Medical image management and processing system.
§ 892.2060Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
§ 892.2070Medical image analyzer.
§ 892.2080Radiological computer aided triage and notification software.
§ 892.2090Radiological computer-assisted detection and diagnosis software.
§ 892.2100Radiological acquisition and/or optimization guidance system.
§ 892.5050Medical charged-particle radiation therapy system.
§ 892.5300Medical neutron radiation therapy system.
§ 892.5650Manual radionuclide applicator system.
§ 892.5700Remote controlled radionuclide applicator system.
§ 892.5710Radiation therapy beam-shaping block.
§ 892.5720Rectal balloon for prostate immobilization.
§ 892.5725Absorbable perirectal spacer.
§ 892.5730Radionuclide brachytherapy source.
§ 892.5740Radionuclide teletherapy source.
§ 892.5750Radionuclide radiation therapy system.
§ 892.5770Powered radiation therapy patient support assembly.
§ 892.5780Light beam patient position indicator.
§ 892.5840Radiation therapy simulation system.
§ 892.5900X-ray radiation therapy system.
§ 892.5930Therapeutic x-ray tube housing assembly.
§ 892.6500Personnel protective shield.
§ 892.6510Cream for x-ray attenuation.