# K213469: Valory

- Pathway: 510(k) (Traditional)
- Applicant: Agfa N.V.
- Decided: Nov 18, 2021 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K803130 (1981). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152639: DR 600, Agfa Healthcare N.V. (2015) Summary page 7.

## Indications for use
The VALORY system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column, and extremities), chest, abdomen, and other body parts on adults and pediatric patients. Applications can be performed with the patient in sitting, standing or lying position. The system is not intended for use in Mammography applications.

Source page: https://510kreport.com/device/K213469
Methodology: https://510kreport.com/methodology