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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 12-306
Standard
NEMA  MS 12-2016
Quantification and Mapping of Geometric Distortion for Special Applications
Scope/Abstract
Defines test methods for measuring the absolute spatial variation of geometric accuracy within magnetic resonance images.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1000 System, Nuclear Magnetic Resonance Spectroscopic Class 2 LNI
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
Relevant FDA Guidance and/or Supportive Publications*
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff. Document issued on: November 18, 2016

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Ting Song
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-7677
  ting.song@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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