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U.S. FDA Medical Device Nuclear Whole Body Counter Requirements


FDA Medical Device Definition: A nuclear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide-aperture detector whose position moves in one direction with respect to the patient. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Registrar Corp assists Nuclear Whole Body Counter companies with:

  • FDA Nuclear Whole Body Counter Establishment Registration
  • FDA Nuclear Whole Body Counter Listing
  • FDA Nuclear Whole Body Counter Label Requirements and Exceptions
  • FDA Nuclear Whole Body Counter Import Information
  • FDA Nuclear Whole Body Counter Detentions (Nuclear Whole Body Counter Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Nuclear Whole Body Counter Manufacturers (Nuclear Whole Body Counter Suppliers)
       - Nuclear Whole Body Counter Distributors
       - Nuclear Whole Body Counter Processors
       - Nuclear Whole Body Counter Repackers
       - Nuclear Whole Body Counter Relabelers
       - Nuclear Whole Body Counter Exporters
       - Nuclear Whole Body Counter Importers
For more information about Nuclear Whole Body Counter Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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