# K122736: DX-D Imaging Package

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Mar 11, 2013 after 173 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.
25 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090672: Agfa Computed Radiography Systems with NX Workstations, Agfa Healthcare N.V. (2009) Summary page 2.
- K092669: DX-D Imaging Package, Agfa Healthcare N.V. (2009) Summary page 2.

## Most influential descendants
- K140771: Philips Eleva Workspot (2014), 15 descendants of its own
- K141192: DR 400 (2014), 7 descendants of its own
- K152639: DR 600 (2015), 6 descendants of its own
- K141736: Philips Prograde; Philips Eleva Workspot for Digital Diagnost (2014), 6 descendants of its own
- K193262: DR 600 with Tomosynthesis (2020), 4 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 for adult, pediatric and neonatal examinations. The DX-D Imaging Package may be used wherever conventional screen-film systems, CR or DR systems may be used. Agfa's DX-D Imaging Package is not indicated for use in mammography.

Source page: https://510kreport.com/device/K122736
Methodology: https://510kreport.com/methodology