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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12-288
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Standard | |
NEMA MS 9-2008 (R2020) Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images |
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Scope/AbstractThis standards publication defines test methods for measuring the signal-to-noise ratio and image uniformity of MR images produced using receive-only phased array coils. Other coil configurations have been addressed in MS 1, MS 3, and MS 6. |
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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
|
Class 2
|
LNH
|
§892.1000 |
System, Nuclear Magnetic Resonance Spectroscopic
|
Class 2
|
LNI
|
§892.1000 |
Coil, Magnetic Resonance, Specialty
|
Class 2
|
MOS
|
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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 Contact
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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. |