Recognized standard
PS 3.1 - 3.20 2022d
FDA recognition 12-349 · NEMA · Radiology
Key facts
| Recognition number | 12-349 |
|---|---|
| Designation | PS 3.1 - 3.20 2022d |
| Title | Digital Imaging and Communications in Medicine (DICOM) Set |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | Digital Imaging and Communications in Medicine (DICOM) is the standard for the communication and management of medical imaging information and related data. The DICOM Standard facilitates interoperability of medical imaging equipment by specifying: For network communications, a set of protocols to… |
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: