# K051528: Mevis Liveranalyser/Liverviewer Software

- Pathway: 510(k) (Traditional)
- Applicant: Mevis Technology GmbH & Co. KG
- Decided: Jul 20, 2005 after 42 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954678 (1996). 6 ancestors in all.
226 later devices descend from it; 6 cite it directly.
1 of 233 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022692: Voxelplus Pacs, Mevisys Co., Ltd. (2002) Summary page 1.
- K040852: Preview Treatment Planning Software, Medical Media Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K061696: Iqqa-Liver Software (2006), 217 descendants of its own
- K071310: Syngo CT Oncology Software Package (2007), 195 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own

## Indications for use
The MeVis LiverAnalyzer / LiverViewer SoftwareTM device is intended for preoperative planning in liver surgery. The device is used to analyze data and to display image analysis and risk analysis results for the preoperative planning in liver surgery, e.g. organ segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections splitting the liver or to calculate safety-margins around lesions identifying affected vascular branches and vascular territories supplied or drained by these branches. Medical image data is derived from various sources (i.e. CT scanners, MRI scanners). Typical users of this system are trained professionals, including physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K051528
Methodology: https://510kreport.com/methodology