510(k) · Cleared
ClearedSyngo, CT Liver Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medi Cal Solutions, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 13, 2014 as substantially equivalent to K061696 (Edda Technology, Inc., 2006) and 1 other predicate after a 351-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- Nov 13, 2014
- Review
- 351 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K954678 (1996). 20 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 3 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 2 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 1 generation backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- This deviceK133643 Syngo, CT Liver AnalysisSiemens Medi Cal Solutions, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK232045 MeVis Liver SuiteMeVis Medical Solutions AG · 2023
Most influential descendants
Showing 1 of 1 · See all- K232045MeVis Liver SuiteMeVis Medical Solutions AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −3 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −2 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −1 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| 0 (this device) | K133643 | Syngo, CT Liver Analysis | Siemens Medi Cal Solutions, Inc. | 2014 | — |
| +1 | K232045 | MeVis Liver Suite | MeVis Medical Solutions AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 7…ble 1: Predicate Devices Manufacturer Predicate Device 510(k) # Clearance Date EDDA IQQA-Liver Software K061696 November 13, 2006 Siemens syngo.CT Oncology Software Package K071310 June 08, 2007 7. Device Descripti… | 2006 |
| * | K071310 | Syngo CT Oncology Software PackageSummary page 7…) # Clearance Date EDDA IQQA-Liver Software K061696 November 13, 2006 Siemens syngo.CT Oncology Software Package K071310 June 08, 2007 7. Device Description syngo.CT Liver Analysis is an image analysis software for CT volume data sets.… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232045 | MeVis Liver Suite | 2023 | 0 |
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 18 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K232045 (MeVis Medical Solutions AG, 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K061696.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
syngo.CT Liver Analysis is an image analysis software for CT volume data sets. It analyses the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver. These regions can be evaluated by exploring the volume of the liver and its vascular territories. Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels of the liver. The following evaluation tools are provided…
Read the full statement (179 words)
syngo.CT Liver Analysis is an image analysis software for CT volume data sets. It analyses the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver. These regions can be evaluated by exploring the volume of the liver and its vascular territories.
Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels of the liver.
The following evaluation tools are provided:
• Computation and manual correction of liver volumes
• Computation and manual correction of tumor volumes and extent
• Computation and manual correction of liver vessel tree structure
• Computation of territories based on vessel branches
• Tumor position in relation to vessels (i.e. 3D visualization of liver, tumor and vessels)
• Manual definition of separation plane proposals
• Computation of volume of liver parts
• Combination of information from different CT and MR phase volumes
syngo.CT Liver Analysis facilitates reporting by using of appropriate reporting tools, for example, volume statistics and key image creation.
You can use syngo.CT Liver Analysis to create a DICOM Structured Report.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133643: Syngo, CT Liver Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133643
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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