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U.S. FDA Medical Device Emission Computed Tomography Requirements: Emission Computed Tomography

FDA Medical Device Definition: An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. 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 Emission Computed Tomography companies with:

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




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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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