# K071063: Linasys

- Pathway: 510(k) (Traditional)
- Applicant: Pathfinder Therapeutics, Inc.
- Decided: Dec 20, 2007 after 248 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: 1 generation back to K944612 (1995). 5 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K983831: VECTORVISION2, Brainlab AG (1999) Summary page 2.
- K003268: Z-Touch, Brainlab AG (2001) Summary page 2.
- K944612: Acustar I Advanced Surgical Navigation System, Codman & Shurtleff, Inc. (1995) Summary page 2.

## Most influential descendants
- K083728: Invision System (2009), 8 descendants of its own
- K121479: AIM (2012), 5 descendants of its own
- K141806: Clear Guide One (2014), 2 descendants of its own
- K093494: Linasys Image-Guided Liver Surgery System (2010), 2 descendants of its own
- K132744: Acessa Guidance System (2014), 1 descendant of its own

## Indications for use
The Linasys 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/K071063
Methodology: https://510kreport.com/methodology