# K041701: Afga CR25.0 Computed Radiography System

- Pathway: 510(k) (Special)
- Applicant: Agfa Corp.
- Decided: Jul 22, 2004 after 30 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: 3 generations back to K904519 (1991). 3 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013138: Adc Compact Plus, Agfa-Gevaert AG (2001) Summary page 1.

## Most influential descendants
- K062223: Agfa Model CR30-X (2006), 8 descendants of its own
- K072010: Quantum Direx System (2007), 5 descendants of its own
- K080905: Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi (2008), 4 descendants of its own
- K193574: Q-Rad System (2020), 3 descendants of its own
- K201373: DRX-Compass (2020), 2 descendants of its own

## Indications for use
The CR25.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR25.0 is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.

Source page: https://510kreport.com/device/K041701
Methodology: https://510kreport.com/methodology