Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
034
|
Date of Entry 01/30/2014
|
FR Recognition Number
|
12-264
|
Standard | |
NEMA MS 11-2010 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging |
|
Scope/AbstractThis document defines methods for determining the gradient -induced electric fields of diagnostic magnetic resonance imaging gradient coils (head and body) under a specific set of conditions. This document does not address the effect of electrical inhomogeneities in the body on internal, gradient - induced, electric fields. |
|
Extent of Recognition
|
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
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 Industry
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998
Guidance for Industry and FDA Staff Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. Document issued on: July 14, 2003
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 Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |