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

12-195

Standard

NEMA MS 6-2008 (R2014, R2020)
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	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

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