Recognized standard
XR 27 Amendment 1-2013
FDA recognition 12-286 · NEMA · Radiology
Key facts
| Recognition number | 12-286 |
|---|---|
| Designation | XR 27 Amendment 1-2013 |
| Title | X-ray equipment for interventional procedures - User Quality Control Mode |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Jan 27, 2015 |
| Device classes | Class 2 |
| Scope (excerpt) | Applies to x-ray equipment intended to perform interventional procedures and defines a set of minimum set of requirements designed to more easily facilitate quality control at the facility level. |
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: