# K092669: DX-D Imaging Package

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Nov 6, 2009 after 67 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K803130 (1981). 21 ancestors in all.
34 later devices descend from it; 4 cite it directly.
0 of 56 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 1.
- K024147: Paxscan 4030 Medical Digital Imaging System, Varian Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K122736: DX-D Imaging Package (2013), 25 descendants of its own
- K140771: Philips Eleva Workspot (2014), 15 descendants of its own
- K103050: DX-D 300 (2010), 8 descendants of its own
- K141192: DR 400 (2014), 7 descendants of its own
- K112670: DX-D 600 (2011), 7 descendants of its own

## Recalls of this device
- Jan 16, 2012 · Not classified · Z-1062-2012: The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot.

## Indications for use
Agfa’s DX-D Imaging Package is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA? image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. Agfa’s DX-D Imaging Package is not indicated for use in mammography.

Source page: https://510kreport.com/device/K092669
Methodology: https://510kreport.com/methodology