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

FDA Medical Device Definition: An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts

Registrar Corp assists Extraoral Source X-Ray System companies with:

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