# K211790: DX-D Imaging Package with XD Detectors

- Pathway: 510(k) (Traditional)
- Applicant: Agfa N.V.
- Decided: Jul 30, 2021 after 50 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: 10 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)
- K200418: Vivix-S VW, Vieworks Co., Ltd. (2020) Summary page 4.

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

Source page: https://510kreport.com/device/K211790
Methodology: https://510kreport.com/methodology