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