Recognized standard
XR 22-2006 (R2020)
FDA recognition 12-165 · NEMA · Radiology
Key facts
| Recognition number | 12-165 |
|---|---|
| Designation | XR 22-2006 (R2020) |
| Title | "Quality Control Manual" Template for Manufacturers of Displays and Workstations 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], a [Manufacturer to specify display or workstation] labeled for final interpretation of images acquired using a full-field digital mammography (FFDM) image acquisition… |
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: