# K042779: Radiotherapy Solution Based on CR

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: Oct 21, 2004 after 15 days
- Product code: IXK (System, Imaging, X-Ray, Electrostatic)
- Device class: 2
- Regulation: 21 CFR 892.1630
- 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032654: Port Cassette, Orex Computed Radiography, Ltd. (2003) Summary page 1.
- K041701: Afga CR25.0 Computed Radiography System, Agfa Corp. (2004) Summary page 1.

## Most influential descendants
- K070920: Fuji IP Cassette Type PC (2007), 0 descendants of its own

## Indications for use
The Radiotherapy Solution Based on CR25.0 is indicated for producing simulation and verification (portal) radiotherapy images to aid in radiation therapy planning and quality control.

Source page: https://510kreport.com/device/K042779
Methodology: https://510kreport.com/methodology