Recognized standard
Standards Publication XR 25 -2019
FDA recognition 12-325 · NEMA · Radiology
Key facts
| Recognition number | 12-325 |
|---|---|
| Designation | Standards Publication XR 25 -2019 |
| Title | Computed Tomography Dose Check |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard applies to particular dose-related notification and alert messages appearing on the operating consoles of CT scanners. This standard is not intended to define all notification, alert, or other messages resident on any CT scanner. |
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: