21 CFR Part 892 — Radiology Devices
Subpart A — General Provisions
Subpart B — Diagnostic Devices
- § 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.
- § 892.2060— 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.
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.