# K062223: Agfa Model CR30-X

- Pathway: 510(k) (Special)
- Applicant: Agfa Corporation
- Decided: Sep 1, 2006 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: 4 generations back to K904519 (1991). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 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.

## Most influential descendants
- 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
- K223842: DRX - Compass (2023), 1 descendant of its own

## Indications for use
The CR30-X is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR30-X is intended to be used mainly in chest, skeletal and gastro-intestinal x-ray imaging applications.

Source page: https://510kreport.com/device/K062223
Methodology: https://510kreport.com/methodology