# K082228: Planisight Linasys

- Pathway: 510(k) (Traditional)
- Applicant: Pathfinder Therapeutics, Inc.
- Decided: Sep 22, 2008 after 46 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: 6 generations back to K954678 (1996). 14 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 38 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 2.
- K051528: Mevis Liveranalyser/Liverviewer Software, Mevis Technology GmbH & Co. KG (2005) Summary page 2.

## Most influential descendants
- K131498: Iqqa-Liver Multimodality Software (2013), 16 descendants of its own
- K091001: Myrian 1.4 (2009), 7 descendants of its own
- K141745: Iqqa-Bodyimaging Software (2014), 6 descendants of its own
- K113620: Myrian 1.11 (2012), 6 descendants of its own
- K142521: Synapse 3D Liver and Kidney Analysis (2014), 5 descendants of its own

## Indications for use
The PlaniSight Linasys TM device is intended for liver surgery preoperative planning. The medical image data utilized is derived from various sources, including CT and MRI scanners. The software provides tools for 3-D visualization and volume measurement of structures in the liver following manual or semi-automatic segmentation of the liver organ, intrahepatic vessels, and physician-identified lesions. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections that divide the liver and calculate margins around lesions. Data can be exported in a format suitable for image-guided surgery with the SurgiSight Linasys device. Typical users of the software are trained professionals, including physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K082228
Methodology: https://510kreport.com/methodology