510(k) · Cleared
ClearedLinasys Image-Guided Liver Surgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pathfinder Therapeutics, Inc. · OEW Tracking, Soft Tissue, Intraoperative
Cleared on Mar 30, 2010 as substantially equivalent to K071063 (Pathfinder Therapeutics, Inc., 2007) and 2 other predicates after a 140-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 30, 2010
- Review
- 140 days
- Class
- Class II
- Product code
- OEW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K944612 (1995). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK944612 Acustar I Advanced Surgical Navigation SystemCodman & Shurtleff, Inc. · 1995
- 1 generation backK071063 LinasysPathfinder Therapeutics, Inc. · 2007
- This deviceK093494 Linasys Image-Guided Liver Surgery SystemPathfinder Therapeutics, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK101979 Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK143024 CAS-One LiverCascination AG · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944612 | Acustar I Advanced Surgical Navigation System | Codman & Shurtleff, Inc. | 1995 | — |
| −1 | K071063 | Linasys | Pathfinder Therapeutics, Inc. | 2007 | — |
| 0 (this device) | K093494 | Linasys Image-Guided Liver Surgery System | Pathfinder Therapeutics, Inc. | 2010 | — |
| +1 | K101979 | Explorer Liver (Passive Tracking) | Pathfinder Therapeutics, Inc. | 2011 | — |
| +2 | K143024 | CAS-One Liver | Cascination AG | 2015 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K071063 | LinasysSummary page 1…t. The Explorerlm Liver system is substantially equivalent to the following FDA cleared frame stereotaxic systems: 1. Linasys Image Guided Liver Surgery System [K(071063] 2. Medtronic Navigation StealthStation with Advanced Contour Registration Software Module [K(954276 & 1(030106] =… | 2007 |
| * | K954276 | StealthstationSummary page 1…1. Linasys Image Guided Liver Surgery System [K(071063] 2. Medtronic Navigation StealthStation with Advanced Contour Registration Software Module [K(954276 & 1(030106] 510(k): K093494 jt7(7Y Pag… | 1996 |
| * | K030106 | Stealthstation System Advanced Contour Registration Software ModuleSummary page 1…inasys Image Guided Liver Surgery System [K(071063] 2. Medtronic Navigation StealthStation with Advanced Contour Registration Software Module [K(954276 & 1(030106] 510(k): K093494 jt7(7Y Page 2of 2… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101979 | Explorer Liver (Passive Tracking) | 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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 12.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K101979 (Pathfinder Therapeutics, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K071063.
How does its category compare?
All OEW devicesOEW Tracking, Soft Tissue, Intraoperative: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OEW
1in 2015
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093494 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093494: Linasys Image-Guided Liver Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093494
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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