# K133643: Syngo, CT Liver Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Nov 13, 2014 after 351 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954678 (1996). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061696: Iqqa-Liver Software, Edda Technology, Inc. (2006) Summary page 7.
- K071310: Syngo CT Oncology Software Package, Siemens AG (2007) Summary page 7.

## Most influential descendants
- K232045: MeVis Liver Suite (2023), 0 descendants of its own

## Indications for use
syngo.CT Liver Analysis is an image analysis software for CT volume data sets. It analyses the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver. These regions can be evaluated by exploring the volume of the liver and its vascular territories. Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels of the liver. The following evaluation tools are provided: • Computation and manual correction of liver volumes • Computation and manual correction of tumor volumes and extent • Computation and manual correction of liver vessel tree structure • Computation of territories based on vessel branches • Tumor position in relation to vessels (i.e. 3D visualization of liver, tumor and vessels) • Manual definition of separation plane proposals • Computation of volume of liver parts • Combination of information from different CT and MR phase volumes syngo.CT Liver Analysis facilitates reporting by using of appropriate reporting tools, for example, volume statistics and key image creation. You can use syngo.CT Liver Analysis to create a DICOM Structured Report.

Source page: https://510kreport.com/device/K133643
Methodology: https://510kreport.com/methodology