Recognized standard
Standards Publication XR 28-2018
FDA recognition 12-330 · NEMA · Radiology
Key facts
| Recognition number | 12-330 |
|---|---|
| Designation | Standards Publication XR 28-2018 |
| Title | Supplemental Requirements for User Information and System Function Related to Dose in CT |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | Identifies uniform and standardized manufacturer's information provided to users of a CT scanner. This information includes perfusion scanning, use of Automatic Exposure Control, organization of dose-related information, a requirement for listing the reference protocols shipped on a CT system. |
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: