Recognized standard
NU 1-2023
FDA recognition 12-383 · NEMA · Radiology
Key facts
| Recognition number | 12-383 |
|---|---|
| Designation | NU 1-2023 |
| Title | Performance Measurements of Gamma Cameras |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This Standards Publication establishes definitions, quantitative measurements of performance characteristics, and reporting techniques for the specification of the following Gamma camera parameters |
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: