# K131408: CR 12-X Digitizer

- Pathway: 510(k) (Special)
- Applicant: Agfa Healthcare N.V.
- Decided: Aug 29, 2013 after 106 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904519 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121948: CR 10-X Digitizer, Agfa Healthcare N.V. (2012) Summary page 1.
- K102619: Computed Raddiography Scanner, 3Disc Americas (2011) Summary page 1.

## Indications for use
Agfa's Computed Radiography (CR) System with CR 12-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used. Agfa's Computed Radiography (CR) System With CR 12-X Digitizer is not indicated for use in mammography.

Source page: https://510kreport.com/device/K131408
Methodology: https://510kreport.com/methodology