# K121095: DX-D Imaging Package

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Aug 16, 2012 after 127 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: 6 generations back to K803130 (1981). 22 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092669: DX-D Imaging Package, Agfa Healthcare N.V. (2009) Summary page 2.

## Most influential descendants
- K142184: DX-D Imaging Package (2014), 2 descendants of its own
- K161368: DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) (2016), 1 descendant of its own
- K172784: DX-D Imaging Package (2017), 0 descendants of its own

## Indications for use
Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used. Agfa's OX-D Imaging Package is not indicated for use in mammography.

Source page: https://510kreport.com/device/K121095
Methodology: https://510kreport.com/methodology