21 C.F.R. PART 892--RADIOLOGY DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 892--RADIOLOGY DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval.
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--DIAGNOSTIC DEVICES
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| Magnetic resonance diagnostic device.
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| Scintillation (gamma) camera.
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| Nuclear whole body counter.
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| Emission computed tomography system.
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| Nuclear rectilinear scanner.
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| Nuclear tomography system.
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| Nuclear whole body scanner.
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| Radionuclide dose calibrator.
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| Nuclear anthropomorphic phantom.
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| Nuclear flood source phantom.
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| Radionuclide rebreathing system.
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| Nuclear sealed calibration source.
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| Nuclear electrocardiograph synchronizer.
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| Radionuclide test pattern phantom.
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| Nonfetal ultrasonic monitor.
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| Ultrasonic pulsed doppler imaging system.
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| Ultrasonic pulsed echo imaging system.
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| Diagnostic ultrasonic transducer.
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| Angiographic x-ray system.
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| Diagnostic x-ray beam-limiting device.
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| Cine or spot fluorographic x-ray camera.
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| Electrostatic x-ray imaging system.
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| Radiographic film marking system.
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| Image-intensified fluoroscopic x-ray system.
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| Non-image-intensified fluoroscopic x-ray system.
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| Diagnostic x-ray high voltage generator.
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| Mammographic x-ray system.
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| Photofluorographic x-ray system.
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| Tomographic x-ray system.
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| Computed tomography x-ray system.
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| Diagnostic x-ray tube housing assembly.
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| Diagnostic x-ray tube mount.
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| Pneumoencephalographic chair.
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| Radiologic patient cradle.
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| Radiographic film cassette.
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| Radiographic film/cassette changer.
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| Radiographic film/cassette changer programmer.
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| Wall-mounted radiographic cassette holder.
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| Radiographic film illuminator.
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| Automatic radiographic film processor.
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| Radiographic head holder.
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| Radiologic quality assurance instrument.
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| Radiographic anthropomorphic phantom.
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| Radiographic intensifying screen.
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| Radiographic ECG/respirator synchronizer.
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| Transilluminator for breast evaluation.
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| Medical image storage device.
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| Medical image communications device.
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| Medical image hardcopy device.
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| Picture archiving and communications system.
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Subparts C-E--[RESERVED]
Subpart F--THERAPEUTIC DEVICES
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| Medical charged-particle radiation therapy system.
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| Medical neutron radiation therapy system.
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| Manual radionuclide applicator system.
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| Remote controlled radionuclide applicator system.
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| Radiation therapy beam-shaping block.
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| Radionuclide brachytherapy source.
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| Radionuclide teletherapy source.
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| Radionuclide radiation therapy system.
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| Powered radiation therapy patient support assembly.
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| Light beam patient position indicator.
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| Radiation therapy simulation system.
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| X-ray radiation therapy system.
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| Therapeutic x-ray tube housing assembly.
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Subpart G--MISCELLANEOUS DEVICES
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| Personnel protective shield.
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