NEMA MS-1-2008 (R2014)

Standard Organization:

NEMA MS-1-2008 (R2014)
Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging

Recognition Date2016-04-04
Recognition List041
Recognition Number12-188
Extent Complete standard
Standards Orgs NEMA National Electrical Manufacturers Association https://www.nema.org/
STG Radiology
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Rationale:

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Scope:

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).

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
§892.1000 Mri Disposable Kit Class 2 OIM
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1000 System, Nuclear Magnetic Resonance Spectroscopic Class 2 LNI

FDA Guidance:

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

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