| NEMA MS 5-2018 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging |
| Recognition Number | Radiology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 12-322 |
| Extent | Complete standard |
| Standards Orgs | NEMA National Electrical Manufacturers Association https://www.nema.org/ |
| STG | Radiology |
| FDA Tech | Ting Song FDA/OMPT/CDRH/OIR/DRH/MREP/ 301-796-7677 ting.song@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1000 | Coil, Magnetic Resonance, Specialty | Class 2 | MOS |
| §892.1000 | Mri Disposable Kit | Class 2 | OIM |
| §892.1000 | System, Nuclear Magnetic Resonance Imaging | Class 2 | LNH |
| §892.1000 | System, Nuclear Magnetic Resonance Spectroscopic | Class 2 | LNI |
| 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 |