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U.S. FDA Medical Device Radiographic Grid Requirements

FDA Medical Device Definition: A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.

Registrar Corp assists Radiographic Grid companies with:

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

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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