# K093494: Linasys Image-Guided Liver Surgery System

- Pathway: 510(k) (Special)
- Applicant: Pathfinder Therapeutics, Inc.
- Decided: Mar 30, 2010 after 140 days
- Product code: OEW (Tracking, Soft Tissue, Intraoperative)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944612 (1995). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071063: Linasys, Pathfinder Therapeutics, Inc. (2007) Summary page 1.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 1.
- K030106: Stealthstation System Advanced Contour Registration Software Module, Medtronic Surgical Navigation Technologies (2003) Summary page 1.

## Most influential descendants
- K101979: Explorer Liver (Passive Tracking) (2011), 1 descendant of its own
- K143024: CAS-One Liver (2015), 0 descendants of its own

## Indications for use
The Explorer Tm Liver device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

Source page: https://510kreport.com/device/K093494
Methodology: https://510kreport.com/methodology