FDA medical devices classification list

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

Subparts C-E [Reserved]

    - 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.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: ;53 FR 1567, Jan. 20, 1988, unless otherwise noted.

Extracted from US.FDA