Diagnostic Devices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Radiology Devices
  7. Diagnostic Devices

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Section
892.1000

Magnetic resonance diagnostic device.

Section
892.1100

Scintillation (gamma) camera.

Section
892.1110

Positron camera.

Section
892.1130

Nuclear whole body counter.

Section
892.1170

Bone densitometer.

Section
892.1180

Bone sonometer.

Section
892.1200

Emission computed tomography system.

Section
892.1220

Fluorescent scanner.

Section
892.1300

Nuclear rectilinear scanner.

Section
892.1310

Nuclear tomography system.

Section
892.1320

Nuclear uptake probe.

Section
892.1330

Nuclear whole body scanner.

Section
892.1350

Nuclear scanning bed.

Section
892.1360

Radionuclide dose calibrator.

Section
892.1370

Nuclear anthropomorphic phantom.

Section
892.1380

Nuclear flood source phantom.

Section
892.1390

Radionuclide rebreathing system.

Section
892.1400

Nuclear sealed calibration source.

Section
892.1410

Nuclear electrocardiograph synchronizer.

Section
892.1420

Radionuclide test pattern phantom.

Section
892.1540

Nonfetal ultrasonic monitor.

Section
892.1550

Ultrasonic pulsed doppler imaging system.

Section
892.1560

Ultrasonic pulsed echo imaging system.

Section
892.1570

Diagnostic ultrasonic transducer.

Section
892.1600

Angiographic x-ray system.

Section
892.1610

Diagnostic x-ray beam-limiting device.

Section
892.1620

Cine or spot fluorographic x-ray camera.

Section
892.1630

Electrostatic x-ray imaging system.

Section
892.1640

Radiographic film marking system.

Section
892.1650

Image-intensified fluoroscopic x-ray system.

Section
892.1660

Non-image-intensified fluoroscopic x-ray system.

Section
892.1670

Spot-film device.

Section
892.1680

Stationary x-ray system.

Section
892.1700

Diagnostic x-ray high voltage generator.

Section
892.1710

Mammographic x-ray system.

Section
892.1715

Full-field digital mammography system.

Section
892.1720

Mobile x-ray system.

Section
892.1730

Photofluorographic x-ray system.

Section
892.1740

Tomographic x-ray system.

Section
892.1750

Computed tomography x-ray system.

Section
892.1760

Diagnostic x-ray tube housing assembly.

Section
892.1770

Diagnostic x-ray tube mount.

Section
892.1820

Pneumoencephalographic chair.

Section
892.1830

Radiologic patient cradle.

Section
892.1840

Radiographic film.

Section
892.1850

Radiographic film cassette.

Section
892.1860

Radiographic film/cassette changer.

Section
892.1870

Radiographic film/cassette changer programmer.

Section
892.1880

Wall-mounted radiographic cassette holder.

Section
892.1890

Radiographic film illuminator.

Section
892.1900

Automatic radiographic film processor.

Section
892.1910

Radiographic grid.

Section
892.1920

Radiographic head holder.

Section
892.1940

Radiologic quality assurance instrument.

Section
892.1950

Radiographic anthropomorphic phantom.

Section
892.1960

Radiographic intensifying screen.

Section
892.1970

Radiographic ECG/respirator synchronizer.

Section
892.1980

Radiologic table.

Section
892.1990

Transilluminator for breast evaluation.

Section
892.2010

Medical image storage device.

Section
892.2020

Medical image communications device.

Section
892.2030

Medical image digitizer.

Section
892.2040

Medical image hardcopy device.

Section
892.2050

Medical image management and processing system.

Section
892.2060

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

Section
892.2070

Medical image analyzer.

Section
892.2080

Radiological computer aided triage and notification software.