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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 12-195
NEMA MS 6-2008 (R2014) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
Scope/Abstract
This standards publication defines test methods for measuring the signal-to-noise ratio and image uniformity of MR images produced using special purpose single-channel non-volume coils or a single channel of an array coil.. ("surface coils"). These methods are applicable to both receive-only and transmit-receive RF coils. This document does not address the use of general head and body coils, special purpose single-channel volume coils (see MS 1 and MS 3), or analysis of data from coils that require multiple receiver channels for operation (array coils, 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 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
 Sunder Rajan
  FDA/OC/CDRH/OSEL/DBP/
  301-796-4194
  sunder.rajan@fda.hhs.gov
 Jana Delfino
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/
  301-796-6503
  jana.delfino@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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