# K071162: Agfa Computed Radiography System with NX2.X Workstations

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare Corp.
- Decided: May 8, 2007 after 12 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K053634 (2006). 1 ancestor in all.
38 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)
- K053634: Computed Radiography System with NX 1.0 Workstation, Agfa Corporation (2006) Summary page 1.

## Most influential descendants
- 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
- K140771: Philips Eleva Workspot (2014), 15 descendants of its own

## Recalls of this device
- Mar 4, 2011 · Not classified · Z-2137-2011: When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system.
- Jun 30, 2010 · Not classified · Z-2100-2010: Monitor fell from the mounting bracket used to support the monitor.

## Indications for use
Agfa’s Computed Radiography Systems with NX 2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The systems can be used with either Musica, Musica? or Musica? Platinum image processing to create radiographic images of the skelston (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 Musica? Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskeletal regions of adult or pediatric patients. Agfa’'s Computed Radiography Systems with NX 2.X software are not indicated for use in mammography.

Source page: https://510kreport.com/device/K071162
Methodology: https://510kreport.com/methodology