Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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12-188
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Standard | |
NEMA MS-1-2008 (R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging |
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Scope/AbstractThis 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). |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§892.1000 |
System, Nuclear Magnetic Resonance Imaging
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Class 2
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LNH
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§892.1000 |
System, Nuclear Magnetic Resonance Spectroscopic
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Class 2
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LNI
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§892.1000 |
Coil, Magnetic Resonance, Specialty
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Class 2
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MOS
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§892.1000 |
Mri Disposable Kit
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Class 2
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OIM
|
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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. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |