510(k) · Cleared
ClearedSyngo CT Oncology Software Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 8, 2007 as substantially equivalent to K022013 (Siemens Medical Solutions USA, Inc., 2002) and 3 other predicates after a 30-day review. Its family tree reaches back 6 generations to 1996. 1 of the 215 devices in its family, counting itself, has a Class I recall. 195 later devices descend from it.
- Decided
- Jun 8, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K954678 (1996). 19 ancestors in all, the oldest K871859 (1987). 195 later devices descend from it, 7 citing it directly. 1 of the 215 devices in this family, counting this one, has a Class I recall.
- 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 deviceK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- Descendant · cites it directly · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 3 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · cites it directly · 54 of its ownK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- Descendant · 4 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
Showing 5 of 195 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 195 · See all- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · cites it directly117descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 2 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 3 generations on63descendants
- K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010 · cites it directly54descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 4 generations on46descendants
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) | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| +1 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +3 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +1 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +4 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 3 | 0 |
| 2014 | 12 | 0 |
| 2015 | 10 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 14 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 9 | 0 |
| 2022 | 17 | 0 |
| 2023 | 18 | 0 |
| 2024 | 16 | 0 |
| 2025 | 17 | 1 |
| 2026 | 16 | 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 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? (4)
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 |
|---|---|---|---|
| * | K022013 | Lungcare CT Software PackageSummary page 2…ftware package: Manufacturer Product 510(k) Clearance date 1. Siemens AG LungCARE CT K022013 07/16/2002 SW Package 2. Edda Technology, Inc. IQQA-Liver.: K0… | 2002 |
| * | K061696 | Iqqa-Liver SoftwareSummary page 2…LungCARE CT K022013 07/16/2002 SW Package 2. Edda Technology, Inc. IQQA-Liver.: K061696 11/13/2006 3. GE Medical Systems Advantage Windows K963345 Tissue Volu… | 2006 |
| * | K963345 | Advantage Windows Tissue Volume OptionSummary page 2…SW Package 2. Edda Technology, Inc. IQQA-Liver.: K061696 11/13/2006 3. GE Medical Systems Advantage Windows K963345 Tissue Volume Option 10/18/1996 4. Siemens AG syngo… | 1996 |
| * | K010938 | Syngo Multimodality WorkstationSummary page 2…Advantage Windows K963345 Tissue Volume Option 10/18/1996 4. Siemens AG syngo Multimodality K010938 06/26/2001 Workstation (feature: Image Fusio… | 2001 |
What descends from it? (195)
See all 1957 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083524 | Syngo Dual Energy with Extended Funationally | 2009 | 117 |
| K093621 | Syngo.Pet&CT Oncology | 2010 | 54 |
| K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864 | 2010 | 18 |
| K111311 | Segmentation Assistant for Prostate-Auto Contouring | 2011 | 9 |
| K120484 | Visia Oncology | 2012 | 8 |
| K113541 | Clearstart SVM System | 2011 | 7 |
| K133643 | Syngo, CT Liver Analysis | 2014 | 1 |
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 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K083524 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 117 descendants of its own.
- 5 other devices also cite its predicate K022013.
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. 2007, 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 Oncology is a self-contained, non invasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and…
Read the full statement (132 words)
syngo CT Oncology is a self-contained, non invasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of lesions and includes dedicated tools to support the physician in lung, liver and lymph node assessment in CT data. Dedicated workflow-support and integrated, accumulative reporting help to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071310 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071310: Syngo CT Oncology Software Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071310
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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