510(k) · Cleared
Clearedsyngo.CT Extended Functionality
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 9, 2017 as substantially equivalent to K112020 (Siemens Medi Cal Solutions, Inc., 2011) and 3 other predicates after a 72-day review. Its family tree reaches back 9 generations to 1996. 6 later devices descend from it.
- Decided
- Feb 9, 2017
- Review
- 72 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K954678 (1996). 89 ancestors in all, the oldest K837107 (1983). 6 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 2 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- This deviceK163341 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK173625 syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK192402 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK203699 syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK214019 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022
- Descendant · 5 generations on · 0 of its ownK221727 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 5 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 4 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 3 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 2 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- This deviceK163341 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018 · cites it directly5descendants
- K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2019 · 2 generations on4descendants
- K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc. · 2021 · 3 generations on3descendants
- K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022 · 4 generations on1descendant
- K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −5 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −4 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −3 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −2 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| 0 (this device) | K163341 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +1 | K173625 | syngo.CT Clinical Extensions | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K192402 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +3 | K203699 | syngo. CT Extended Functionalities | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +4 | K214019 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +5 | K221727 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 7 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K112020 | Syngo.CT Vascular AnalysisSummary page 5…ge 5 === III. Predicate Device Predicate Device: Trade Name: syngo.CT Vascular Analysis 510(k) Number: K112020 Clearance Date: 08/18/2011 Classification Name: System, X-Ray, Tomography, Computed… | 2011 |
| * | K143196 | syngo.CT Lung CADSummary page 5…ss II Product Code: JAK Predicate Device: Trade Name: syngo.CT Lung CAD 510(k) Number: K143196 Clearance Date: 05/12/2015 Classification Name: Lung Computed Tomography System, Computer-… | 2015 |
| * | K971054 | Osteo CT for the Somatom AR Family and Plus 4 CT SystemsSummary page 5…Product Code: OEB Predicate Device: Trade Name: Osteo CT Option for SOMATOM CT Systems 510(k) Number: K971054 Clearance Date: 06/13/1997 Classification Name: System, X-Ray, Tomography, Computed Classificati… | 1997 |
| * | K053024 | Syngo Neuro Dsa CTSummary page 5…JAK Subsequent Product Code: KGI Predicate Device: Trade Name: syngo Neuro DSA CT 510(k) Number: K053024 Clearance Date: 11/04/2005 Classification Name: System, X-Ray, Tomography, Computed… | 2005 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173625 | syngo.CT Clinical Extensions | 2018 | 5 |
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 21 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 18 of the 89 ancestors have a recall of any class.
- Of its descendants, K173625 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K112020.
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. 2017, 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 Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners.
An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.
Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163341 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163341: syngo.CT Extended Functionality.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163341
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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