# K141602: DX-D Imaging Package

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Sep 12, 2014 after 88 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: 7 generations back to K803130 (1981). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122736: DX-D Imaging Package, Agfa Healthcare N.V. (2013) Summary page 4.
- K092238: Agfa Computed Radiography Systems with DX-G Digitizers, Agfa Healthcare N.V. (2009) Summary page 4.

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

Source page: https://510kreport.com/device/K141602
Methodology: https://510kreport.com/methodology