# K172784: DX-D Imaging Package

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Oct 13, 2017 after 28 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: 12 generations back to K981556 (1998). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161368: DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s), Agfa Healthcare N.V. (2016) Summary page 9.
- K162344: Innolux Ric, Innolux Corporation (2016) Summary page 9.

## 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 be used. Agfa's DX-D Imaging Package is not indicated for use in mammography.

Source page: https://510kreport.com/device/K172784
Methodology: https://510kreport.com/methodology