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

FDA Medical Device Definition: A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories

Registrar Corp assists Mammographic X-Ray System companies with:

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