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

12-188

Standard

NEMA MS-1-2008 (R2020)
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	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
§892.1000	Mri Disposable Kit	Class 2	OIM

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