510(k) · Cleared
Recalled · Class II · 2019syngo.CT Cardiac Planning
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare GmbH · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 21, 2017 as substantially equivalent to K123585 (Siemens Medical Solutions USA, Inc., 2012) after an 86-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 21, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K954678 (1996). 91 ancestors in all, the oldest K837107 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations between
- 3 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 1 generation backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- This deviceK170221 syngo.CT Cardiac PlanningSiemens Healthcare GmbH · 2017
- Descendant · cites it directly · 0 of its ownK200515 syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 9 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 8 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 7 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 6 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 5 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 4 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 3 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 1 generation backK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- This deviceK170221 syngo.CT Cardiac PlanningSiemens Healthcare GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −9 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −8 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −7 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −6 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −5 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −4 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −3 | 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 | — |
| −1 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| 0 (this device) | K170221 | syngo.CT Cardiac Planning | Siemens Healthcare GmbH | 2017 | — |
| +1 | K200515 | syngo.CT Cardiac Planning | Siemens Medical Soultions USA, Inc. | 2020 | — |
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 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K123585 | Syngo, CT Cardiac FunctionSummary page 5…Class: Class II Product Code: 90JAK III. Predicate Device Trade Name: syngo.CT Cardiac Function 510(k) Number: K123585 Clearance Date: December 20, 2012 Classification Name: Computed Tomography X-ray System Classification Panel:… | 2012 |
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 |
|---|---|---|---|
| K200515 | syngo.CT Cardiac Planning | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2019 | Class II | Z-1113-2019 | Software design | There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 20 of the 91 ancestors have a recall of any class.
- Of its descendants, K200515 (Siemens Medical Soultions USA, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123585.
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 Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of serving as input for planning of cardiovascular procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170221: syngo.CT Cardiac Planning.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170221
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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