Title 21, Part 892 — Radiology Devices

Scope.

Effective dates of requirement for premarket approval.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Magnetic resonance diagnostic device.

Liver iron concentration imaging companion diagnostic for deferasirox.

Scintillation (gamma) camera.

Positron camera.

Nuclear whole body counter.

Bone densitometer.

Bone sonometer.

Emission computed tomography system.

Fluorescent scanner.

Nuclear rectilinear scanner.

Nuclear tomography system.

Nuclear uptake probe.

Nuclear whole body scanner.

Nuclear scanning bed.

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.

Spot-film device.

Stationary x-ray system.

Diagnostic x-ray high voltage generator.

Mammographic x-ray system.

Full-field digital mammography system.

Mobile 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.

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 grid.

Radiographic head holder.

Radiologic quality assurance instrument.

Radiographic anthropomorphic phantom.

Radiographic intensifying screen.

Radiographic ECG/respirator synchronizer.

Radiologic table.

Transilluminator for breast evaluation.

Medical image storage device.

Medical image communications device.

Medical image digitizer.

Medical image hardcopy device.

Medical image management and processing system.

Radiological computer-assisted diagnostic software for lesions suspicious of cancer.

Medical image analyzer.

Radiological computer aided triage and notification software.

Radiological computer-assisted detection and diagnosis software.

892.2100 Radiological acquisition and/or optimization guidance system.

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.

Rectal balloon for prostate immobilization.

Absorbable perirectal spacer.

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.

Personnel protective shield.

Cream for x-ray attenuation.