TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
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.
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