# K122119: DX-D Full Leg Full Spine

- Pathway: 510(k) (Traditional)
- Applicant: Afga Healthcare N.V.
- Decided: Sep 13, 2012 after 58 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 1 generation back to K000159 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000159: Agfa Diagnostic Center Adc, Adc Compact, and Adc Solo, Agfa Corp. (2000) Summary page 1.

## Indications for use
Agfa's DX-D FLFS is indicated for acquiring images for measurements in the orthopedic field (skeleton).

Source page: https://510kreport.com/device/K122119
Methodology: https://510kreport.com/methodology