• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 12-322
NEMA  MS 5-2018
Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
This standards publication provides a method for determining the slice thickness of proton images. Both the typical and the typically thinnest slices in routine clinical use for a particular system are determined at one location within the specification volume and only one of the three orthogonal orientations (transverse, sagittal, or coronal). Imaging types and conditions not addressed by this standard include spectroscopy, chemical shift imaging, and warped slices.
Extent of Recognition
Complete standard
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
§892.1000 Mri Disposable Kit Class 2 OIM
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, Issued November 18, 2016

Guidance for Industry and Food and Drug Administration Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices, Issued June 20. 2014

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
 Ting Song
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.