Diagnostic Devices | Midpage

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Code of Federal Regulations

Subpart B

Diagnostic Devices

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.892.2055Radiological machine learning-based quantitative imaging software with predetermined change control plan.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.