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U.S. FDA Medical Device Nuclear Whole Body Scanner 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 Scanner companies with:

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