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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 12-264: NEMA MS 11-2010, determination of gradient-induced electric fields in diagnostic magnetic resonance imaging. (Radiology)

Date of Standard: 2010. 
Address of Standards Development Organization:
 National Electrical Manufacturers Association (NEMA)
  1300 North 17th Street
  Suite 1847
  Rosslyn, VA 22209
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Magnetic Resonance Imaging Systems
Processes Affected:
510(k), Methodology for Measurement of Device Characteristics
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1000 System, Nuclear Magnetic Resonance Spectroscopic Class 2 LNI
Relevant Guidance:
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
FDA Technical Contact:
 Sunder Rajan
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 1113
  Silver Spring MD 20993
  301/796-4194
  email: sunder.rajan@fda.hhs.gov
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