510(k) · Cleared
ClearedPlanisight Linasys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pathfinder Therapeutics, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 22, 2008 as substantially equivalent to K061696 (Edda Technology, Inc., 2006) and 1 other predicate after a 46-day review. Its family tree reaches back 6 generations to 1996. 23 later devices descend from it.
- Decided
- Sep 22, 2008
- Review
- 46 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K954678 (1996). 14 ancestors in all, the oldest K871859 (1987). 23 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 2 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 1 generation backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- This deviceK082228 Planisight LinasysPathfinder Therapeutics, Inc. · 2008
- Descendant · cites it directly · 16 of its ownK131498 Iqqa-Liver Multimodality SoftwareEdda Technology, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK091001 Myrian 1.4Intrasense · 2009
- Descendant · 2 generations on · 6 of its ownK141745 Iqqa-Bodyimaging SoftwareEdda Technology · 2014
- Descendant · cites it directly · 6 of its ownK113620 Myrian 1.11Intrasense · 2012
- Descendant · 2 generations on · 5 of its ownK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K131498Iqqa-Liver Multimodality SoftwareEdda Technology, Inc. · 2013 · cites it directly16descendants
- K091001Myrian 1.4Intrasense · 2009 · cites it directly7descendants
- K141745Iqqa-Bodyimaging SoftwareEdda Technology · 2014 · 2 generations on6descendants
- K113620Myrian 1.11Intrasense · 2012 · cites it directly6descendants
- K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −2 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −1 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| 0 (this device) | K082228 | Planisight Linasys | Pathfinder Therapeutics, Inc. | 2008 | — |
| +1 | K131498 | Iqqa-Liver Multimodality Software | Edda Technology, Inc. | 2013 | — |
| +1 | K091001 | Myrian 1.4 | Intrasense | 2009 | — |
| +2 | K141745 | Iqqa-Bodyimaging Software | Edda Technology | 2014 | — |
| +1 | K113620 | Myrian 1.11 | Intrasense | 2012 | — |
| +2 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K061696 | Iqqa-Liver SoftwareSummary page 2…te devices. The device is substantially equivalent to the following FDA cleared Radiological Image Processing Systems: 1. IQQA Liver Software (EDDA Technology, K061696) 2. MeVis Liver Analyzer / Liver Viewer Software (MeVis-Center for Medical Diagnostic Systems and Visualiza… | 2006 |
| * | K051528 | Mevis Liveranalyser/Liverviewer SoftwareSummary page 2…Software (EDDA Technology, K061696) 2. MeVis Liver Analyzer / Liver Viewer Software (MeVis-Center for Medical Diagnostic Systems and Visualization, K051528) VI. Device Description: The PlaniSight Linasys TM Liver Surgical Planning Software (LSPS) is a self-contained, PC-base… | 2005 |
What descends from it? (23)
See all 233 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K131498 (Edda Technology, Inc., 2013) has gone furthest, with 16 descendants of its own.
- 6 other devices also cite its predicate K061696.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (110 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082228: Planisight Linasys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082228
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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