# K081963: Agfa Computed Radiography Systems with NX2008 Workstations

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare Corporation
- Decided: Jul 25, 2008 after 15 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: 2 generations back to K053634 (2006). 2 ancestors in all.
37 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071162: Agfa Computed Radiography System with NX2.X Workstations, Agfa Healthcare Corp. (2007) Summary page 1.

## Most influential descendants
- 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
- K140771: Philips Eleva Workspot (2014), 15 descendants of its own
- K103050: DX-D 300 (2010), 8 descendants of its own

## Indications for use
Agfa's Computed Radlography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physiclan with diagnosis. The systems can be used with either Musica, Musica? or Musica? Platinum image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control. . When used with Muslca? Platinum software the systems are indicated for creating high quality Images of the thorax, abdomen or musculoskeletal regions of adult or padiatric patients. Agfa's Computed Radiography Systems with NX 2008 software are not indicated for use in mammography.

Source page: https://510kreport.com/device/K081963
Methodology: https://510kreport.com/methodology