510(k) · Cleared
ClearedMevis Liveranalyser/Liverviewer Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mevis Technology GmbH & Co. KG · LLZ System, Image Processing, Radiological
Cleared on Jul 20, 2005 as substantially equivalent to K022692 (Mevisys Co., Ltd., 2002) and 1 other predicate after a 42-day review. Its family tree reaches back 4 generations to 1996. 1 of the 233 devices in its family, counting itself, has a Class I recall. 226 later devices descend from it.
- Decided
- Jul 20, 2005
- Review
- 42 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954678 (1996). 6 ancestors in all. 226 later devices descend from it, 6 citing it directly. 1 of the 233 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- This deviceK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- Descendant · cites it directly · 217 of its ownK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- Descendant · 2 generations on · 195 of its ownK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- Descendant · 3 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- Descendant · 4 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 5 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 226 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 226 · See all- K061696Iqqa-Liver SoftwareEdda Technology, Inc. · 2006 · cites it directly217descendants
- K071310Syngo CT Oncology Software PackageSiemens AG · 2007 · 2 generations on195descendants
- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 3 generations on117descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 4 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 5 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| 0 (this device) | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| +1 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| +2 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| +3 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +4 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +5 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 14 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 16 | 0 |
| 2019 | 17 | 0 |
| 2020 | 19 | 0 |
| 2021 | 10 | 0 |
| 2022 | 17 | 0 |
| 2023 | 18 | 0 |
| 2024 | 20 | 0 |
| 2025 | 19 | 1 |
| 2026 | 19 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K022692 | Voxelplus PacsSummary page 1…oog R~~adiological Regulation Number 11892.2050 1892.2050 510(k) Number K022692 ]1<040852 Preview Treatment De… | 2002 |
| * | K040852 | Preview Treatment Planning SoftwareSummary page 1…R~~adiological Regulation Number 11892.2050 1892.2050 510(k) Number K022692 ]1<040852 Preview Treatment Device Name… | 2004 |
What descends from it? (226)
See all 2266 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K061696 (Edda Technology, Inc., 2006) has gone furthest, with 217 descendants of its own.
- 3 other devices also cite its predicate K022692.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MeVis LiverAnalyzer / LiverViewer SoftwareTM device is intended for preoperative planning in liver surgery. The device is used to analyze data and to display image analysis and risk analysis results for the preoperative planning in liver surgery, e.g. organ segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories. Preoperative evaluation of specific surgery strategies is supported by…
Read the full statement (119 words)
The MeVis LiverAnalyzer / LiverViewer SoftwareTM device is intended for preoperative planning in liver surgery. The device is used to analyze data and to display image analysis and risk analysis results for the preoperative planning in liver surgery, e.g. organ segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections splitting the liver or to calculate safety-margins around lesions identifying affected vascular branches and vascular territories supplied or drained by these branches.
Medical image data is derived from various sources (i.e. CT scanners, MRI scanners).
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051528: Mevis Liveranalyser/Liverviewer Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051528
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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