Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

041

Date of Entry 04/04/2016

FR Recognition Number

12-196

Standard

NEMA MS 2-2008 (R2020)
Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images

Scope/Abstract

Describes a method for determining the maximum percent difference between measured distances in an image and actual corresponding phantom dimensions. Evaluates geometric distortion in three orthogonal planes passing through the center of the specification volume.

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*

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

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 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