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U.S. FDA Medical Device Image-Intensified Fluoroscopic X-Ray Requirements: Image-Intensified Fluoroscopic X-Ray

FDA Medical Device Definition: An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories

Registrar Corp assists Image-Intensified Fluoroscopic X-Ray companies with:

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