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U.S. FDA Medical Device Magnetic Resonance Diagnostic Device Requirements: Magnetic Resonance Diagnostic Device

FDA Medical Device Definition: A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information)

Registrar Corp assists Magnetic Resonance Diagnostic Device companies with:

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