Recognized standard
XR 24-2008 (R2014)
FDA recognition 12-230 · NEMA · Radiology
Key facts
| Recognition number | 12-230 |
|---|---|
| Designation | XR 24-2008 (R2014) |
| Title | Primary user controls for interventional angiography x-ray equipment |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Jan 27, 2015 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | Offers a unified approach to primary user control function as a means of ensuring that the method of control for interventional x-ray equipment is consistent for all manufacturers. |
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: