# K974597: Adc Compact (Agfa Diagnostic Center)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp., Agfa Div.
- Decided: Mar 9, 1998 after 90 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904519 (1991). 1 ancestor in all.
436 later devices descend from it; 4 cite it directly.
1 of 438 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904519: Agfa Diagnostic Center (Adc), Enhanced Imaging Technologies, Inc. (1991) Summary page 1.

## Most influential descendants
- K013138: Adc Compact Plus (2001), 431 descendants of its own
- 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

## Recalls of this device
- Nov 18, 2005 · Not classified · Z-0352-06: Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.

## Indications for use
To provide diagnostic quality images for aid in physician diagnosi‘s: Tt;is is used in the X-Ray imaging modality, mainly in Chest, Skeleton, and Gastro-Intestinal imaging applications.

Source page: https://510kreport.com/device/K974597
Methodology: https://510kreport.com/methodology