510(k) · Cleared

Cleared

Linasys

K071063510(k) TraditionalCleared Dec 20, 2007248-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pathfinder Therapeutics, Inc. · OEW Tracking, Soft Tissue, Intraoperative

Cleared on Dec 20, 2007 as substantially equivalent to K954276 (Surgical Navigation Technologies, Inc., 1996) and 4 other predicates after a 248-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.

Decided: Dec 20, 2007
Review: 248 days
Class: Class II
Product code: OEW
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K944612 (1995). 5 ancestors in all. 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK944612 Acustar I Advanced Surgical Navigation SystemCodman & Shurtleff, Inc. · 1995
This deviceK071063 LinasysPathfinder Therapeutics, Inc. · 2007
Descendant · cites it directly · 8 of its ownK083728 Invision SystemInneroptic Technology, Inc. · 2009
Descendant · 2 generations on · 5 of its ownK121479 AIMInneroptic Technology, Inc. · 2012
Descendant · 3 generations on · 2 of its ownK141806 Clear Guide OneClear Guide Medical · 2014
Descendant · cites it directly · 2 of its ownK093494 Linasys Image-Guided Liver Surgery SystemPathfinder Therapeutics, Inc. · 2010
Descendant · 3 generations on · 1 of its ownK132744 Acessa Guidance SystemHalt Medical, Inc. · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009high 2 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 10 · See all

K083728Invision SystemInneroptic Technology, Inc. · 2009 · cites it directly8descendants
K121479AIMInneroptic Technology, Inc. · 2012 · 2 generations on5descendants
K141806Clear Guide OneClear Guide Medical · 2014 · 3 generations on2descendants
K093494Linasys Image-Guided Liver Surgery SystemPathfinder Therapeutics, Inc. · 2010 · cites it directly2descendants
K132744Acessa Guidance SystemHalt Medical, Inc. · 2014 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944612	Acustar I Advanced Surgical Navigation System	Codman & Shurtleff, Inc.	1995	—
0 (this device)	K071063	Linasys	Pathfinder Therapeutics, Inc.	2007	—
+1	K083728	Invision System	Inneroptic Technology, Inc.	2009	—
+2	K121479	AIM	Inneroptic Technology, Inc.	2012	—
+3	K141806	Clear Guide One	Clear Guide Medical	2014	—
+1	K093494	Linasys Image-Guided Liver Surgery System	Pathfinder Therapeutics, Inc.	2010	—
+3	K132744	Acessa Guidance System	Halt Medical, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	1	0
2001	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2011	1	0
2012	1	0
2014	2	0
2015	1	0
2018	1	0
2020	1	0
2022	1	0

FIG. 1 — Lineage of K071063, 1995–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K954276	Stealthstation Summary page 1 …ntially equivalent to the following FDA cleared frame stereotaxic systems: 1. Medtronic Navigation StealthStation with Advanced Contour Registration Software Module [K954276 & K030106] 6-1 2. BrainLAB VectorVision2 Image Guided Surgery System…	Surgical Navigation Technologies, Inc.	1996	1
*	K030106	Stealthstation System Advanced Contour Registration Software Module Summary page 1 …uivalent to the following FDA cleared frame stereotaxic systems: 1. Medtronic Navigation StealthStation with Advanced Contour Registration Software Module [K954276 & K030106] 6-1 2. BrainLAB VectorVision2 Image Guided Surgery System with z-to…	Medtronic Surgical Navigation Technologies	2003	—
*	K983831	VECTORVISION2 Summary page 2 …Module [K954276 & K030106] 6-1 2. BrainLAB VectorVision2 Image Guided Surgery System with z-touch device [K98383 1&K003268] 3. J&J ACUSTAR I Advanced Surgical Navigation System [K944612] VI. Device Description: The Linasys (Liver Navigati…	Brainlab AG	1999	—
*	K003268	Z-Touch Summary page 2 …954276 & K030106] 6-1 2. BrainLAB VectorVision2 Image Guided Surgery System with z-touch device [K98383 1&K003268] 3. J&J ACUSTAR I Advanced Surgical Navigation System [K944612] VI. Device Description: The Linasys (Liver Navigation Syste…	Brainlab AG	2001	—
*	K944612	Acustar I Advanced Surgical Navigation System Summary page 2 …-1 2. BrainLAB VectorVision2 Image Guided Surgery System with z-touch device [K98383 1&K003268] 3. J&J ACUSTAR I Advanced Surgical Navigation System [K944612] VI. Device Description: The Linasys (Liver Navigation System) is an image-guided surgery medical device specifically design…	Codman & Shurtleff, Inc.	1995	—

Also cleared against K954276: 22 other devices →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K083728	Invision System	Inneroptic Technology, Inc.	2009	8
K093494	Linasys Image-Guided Liver Surgery System	Pathfinder Therapeutics, Inc.	2010	2
K101979	Explorer Liver (Passive Tracking)	Pathfinder Therapeutics, Inc.	2011	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 5 ancestors has a recall of any class.
Of its descendants, K083728 (Inneroptic Technology, Inc., 2009) has gone furthest, with 8 descendants of its own.
22 other devices also cite its predicate K954276.

How does its category compare?

All OEW devices

OEW Tracking, Soft Tissue, Intraoperative: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · OEW

1in 2015

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OEW

Too few OEW 510(k)s in any year since 2007 to give a median.

Recalls per year · OEW

No recall names OEW since 2007.

Adverse event reports per year · OEW

1in 2012

2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code OEW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	1	—	0
2012	0	—	1
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071063 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071063: Linasys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071063

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026