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U.S. FDA Medical Device Computed Tomography X-Ray System Requirements: Computed Tomography X-Ray System

FDA Medical Device Definition: A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories

Registrar Corp assists Computed Tomography X-Ray System companies with:

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