Recognized standard
Std 3333.2.1-2015
FDA recognition 12-292 · IEEE · Radiology
Key facts
| Recognition number | 12-292 |
|---|---|
| Designation | Std 3333.2.1-2015 |
| Title | IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling |
| Standards developer | Institute of Electrical and Electronic Engineers |
| Specialty area | Radiology |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This standard includes volume- and surface-rendering techniques for 3D reconstruction from 2D medical images. Also, it contains a texturing method of 3D medical data for realistic visualization. Standardization related to medical services includes medical equipment utilizing 2D images, 3D medical… |
At a glance
- None 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: