Recognized standard
XR 23-2006 (R2020)
FDA recognition 12-166 · NEMA · Radiology
Key facts
| Recognition number | 12-166 |
|---|---|
| Designation | XR 23-2006 (R2020) |
| Title | "Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Sep 9, 2008 |
| Device classes | Class 2 |
| Scope (excerpt) | This document defines the minimum set of quality control (QC) tests to be applied to the [Manufacturer to enter commercial name of hardcopy device], a hardcopy output device that receives images from an FFDM system, and reproduces them on [Manufacturer to enter description of hardcopy medium] for… |
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: