# K010938: Syngo Multimodality Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 26, 2001 after 89 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
721 later devices descend from it; 13 cite it directly.
1 of 722 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040970: Leonardo (2004), 420 descendants of its own
- K063762: Syngo Circulation Software Package with Extended Functionality (2007), 263 descendants of its own
- K030982: Syngo Colonography Software Package (2003), 227 descendants of its own
- K041484: Undecided (2004), 222 descendants of its own
- K053301: Cedara I-Response Cedara Pet/CT (2006), 221 descendants of its own

## Recalls of this device
- Sep 12, 2008 · Not classified · Z-0324-2009: Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.
- Sep 28, 2004 · Not classified · Z-0163-05: Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Feb 28, 2003 · Not classified · Z-1089-03: software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
- Feb 28, 2003 · Not classified · Z-1088-03: software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
- Oct 11, 2002 · Not classified · Z-0841-03: Perfusion CT is displaying a higher gray and color values than normal. A software problem.

Source page: https://510kreport.com/device/K010938
Methodology: https://510kreport.com/methodology