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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 12-188
NEMA MS-1-2008 (R2014) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
Scope/Abstract
This document defines methods for measuring the signal-to-noise ratio of magnetic resonance images obtained under a specific set of conditions, and using single-channel volume receiver coils. This document does not address the use of special purpose coils (see MS 6) or coils that employ multiple receiver channels for operation (see MS 9).
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
§892.1000 Mri Disposable Kit Class 2 OIM
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1000 System, Nuclear Magnetic Resonance Spectroscopic Class 2 LNI
Relevant FDA Guidance and/or Supportive Publications*
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073817.htm
FDA Technical Contacts
 Ting Song
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-7677
  ting.song@fda.hhs.gov
 Sunder Rajan
  FDA/OC/CDRH/OSEL/DBP/
  301-796-4194
  sunder.rajan@fda.hhs.gov
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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