# K121948: CR 10-X Digitizer

- Pathway: 510(k) (Special)
- Applicant: Agfa Healthcare N.V.
- Decided: Jul 20, 2012 after 17 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904519 (1991). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062223: Agfa Model CR30-X, Agfa Corporation (2006) Summary page 1.

## Most influential descendants
- K131408: CR 12-X Digitizer (2013), 0 descendants of its own

## Recalls of this device
- Feb 7, 2013 · Class II · Z-0970-2013: The cassettes were shipped with the wrong IP (image plate) size bar code.

## Indications for use
Agfa's Computed Radiography (CR) System with CR 10-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 10-X Digitizer is not indicated for use in mammography.

Source page: https://510kreport.com/device/K121948
Methodology: https://510kreport.com/methodology