# K092238: Agfa Computed Radiography Systems with DX-G Digitizers

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Aug 11, 2009 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K053634 (2006). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090672: Agfa Computed Radiography Systems with NX Workstations, Agfa Healthcare N.V. (2009) Summary page 1.

## Most influential descendants
- K141602: DX-D Imaging Package (2014), 0 descendants of its own

## Recalls of this device
- Dec 6, 2011 · Not classified · Z-0591-2012: Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle.
- Oct 8, 2010 · Not classified · Z-0464-2011: Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.

## Indications for use
Agfa’s Computed Radiography Systems with DX-G Digitizers 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 skulf, spinal column and extremities) chest, abdomen and other body parts. System options and accessories are avaitable for: Pediatric imaging Full leg/full spine Radiotherapy planning and QC Musica? Platinum (thorax, abdomen or musculoskeletal regions of adult or pediatric patients) e Musica? Neonatal Agfa’s Computed Radiography Systems with NX Workstations are not.indicated for use in mammography.

Source page: https://510kreport.com/device/K092238
Methodology: https://510kreport.com/methodology