# K013138: Adc Compact Plus

- Pathway: 510(k) (Special)
- Applicant: Agfa-Gevaert AG
- Decided: Sep 28, 2001 after 9 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 K904519 (1991). 2 ancestors in all.
431 later devices descend from it; 4 cite it directly.
1 of 434 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974597: Adc Compact (Agfa Diagnostic Center), Bayer Corp., Agfa Div. (1998) Summary page 1.

## Most influential descendants
- K022881: Cedara I-Softview (2002), 413 descendants of its own
- K040468: Cedara I-Softview and Cedara I-Readmammo (2004), 255 descendants of its own
- K053301: Cedara I-Response Cedara Pet/CT (2006), 221 descendants of its own
- K071950: Syngo Trued (2007), 201 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own

## Indications for use
The ADC Compact Plus is indicated for use to provide diagnostic quality images for aid in physician diagnosis. The ADC Compact Plus is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.

Source page: https://510kreport.com/device/K013138
Methodology: https://510kreport.com/methodology