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U.S. FDA Medical Device Nuclear Rectilinear Scanner Requirements


FDA Medical Device Definition: A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions 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 Rectilinear Scanner companies with:

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