# K050810: Agfa CR50.0

- Pathway: 510(k) (Special)
- Applicant: Agfa Corp.
- Decided: Apr 21, 2005 after 21 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904519 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041701: Afga CR25.0 Computed Radiography System, Agfa Corp. (2004) Summary page 1.

## Recalls of this device
- Jun 28, 2006 · Not classified · Z-0031-2007: Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
- Nov 3, 2005 · Not classified · Z-0855-06: Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.

## Indications for use
The CR50.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR50.0 is intended to be used mainly in chest, skeletal and gastro-intestinal imaging applications.

Source page: https://510kreport.com/device/K050810
Methodology: https://510kreport.com/methodology