# K090672: Agfa Computed Radiography Systems with NX Workstations

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: May 18, 2009 after 66 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: 3 generations back to K053634 (2006). 3 ancestors in all.
36 later devices descend from it; 3 cite 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)
- K081963: Agfa Computed Radiography Systems with NX2008 Workstations, Agfa Healthcare Corporation (2008) Summary page 1.

## Most influential descendants
- 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
- K141192: DR 400 (2014), 7 descendants of its own

## Recalls of this device
- Dec 21, 2016 · Class II · Z-2735-2017: A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the 
- Jun 22, 2009 · Not classified · Z-1889-2009: After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.

## Indications for use
Agfa’s Computed Radiography Systems with NX Workstations are indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with either Musica or Musica® image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. System options and accessories are available for: • Pediatric imaging • Full leg/full spine • Radiotherapy planning and QC • Musica® Platinum (thorax, abdomen or musculoskeletal regions of adult or pediatric patients) • Musica® Neonatal Agfa's Computed Radiography Systems with NX Workstations are not indicated for use in mammography.

Source page: https://510kreport.com/device/K090672
Methodology: https://510kreport.com/methodology