# K053634: Computed Radiography System with NX 1.0 Workstation

- Pathway: 510(k) (Special)
- Applicant: Agfa Corporation
- Decided: Jan 17, 2006 after 19 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
No predicates in its family tree.
46 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Agfa's Computed Radiography System with QS 3.0 workstation: named in the summary without a submission number

## Most influential descendants
- K071162: Agfa Computed Radiography System with NX2.X Workstations (2007), 38 descendants of its own
- K081963: Agfa Computed Radiography Systems with NX2008 Workstations (2008), 37 descendants of its own
- K090672: Agfa Computed Radiography Systems with NX Workstations (2009), 36 descendants of its own
- K092669: DX-D Imaging Package (2009), 34 descendants of its own
- K122736: DX-D Imaging Package (2013), 25 descendants of its own

## Indications for use
Agfa's Computed Radiography Systems with NX1.0 workstations are indicated to provide diagnostic quality images to aid the physician with diagnosis.

Source page: https://510kreport.com/device/K053634
Methodology: https://510kreport.com/methodology