Recognized standard
MS 2-2008 (R2020)
FDA recognition 12-196 · NEMA · Radiology
Key facts
| Recognition number | 12-196 |
|---|---|
| Designation | MS 2-2008 (R2020) |
| Title | Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | Describes a method for determining the maximum percent difference between measured distances in an image and actual corresponding phantom dimensions. Evaluates geometric distortion in three orthogonal planes passing through the center of the specification volume. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: