510(k) · Cleared
ClearedSyngo, CT Cardiac Function
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 Dec 20, 2012 as substantially equivalent to K110366 (Siemens AG, 2011) and 2 other predicates after a 29-day review. Its family tree reaches back 9 generations to 1996. 14 later devices descend from it.
- Decided
- Dec 20, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K954678 (1996). 90 ancestors in all, the oldest K837107 (1983). 14 later devices descend from it, 2 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 deviceK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- Descendant · 2 generations on · 9 of its ownK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- Descendant · 3 generations on · 6 of its ownK230223 iCAC DeviceBunkerhill, Inc. · 2023
- Descendant · 4 generations on · 3 of its ownK243229 Bunkerhill AVCBunkerHill Health · 2025
- Descendant · cites it directly · 1 of its ownK170221 syngo.CT Cardiac PlanningSiemens Healthcare GmbH · 2017 · Recalled
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 deviceK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019 · cites it directly11descendants
- K210085HealthCCSngZebra Medical Vision, Ltd. · 2021 · 2 generations on9descendants
- K230223iCAC DeviceBunkerhill, Inc. · 2023 · 3 generations on6descendants
- K243229Bunkerhill AVCBunkerHill Health · 2025 · 4 generations on3descendants
- K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH · 2017 · cites it directly1descendant
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) | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +1 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +2 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| +3 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
| +4 | K243229 | Bunkerhill AVC | BunkerHill Health | 2025 | — |
| +1 | K170221 | syngo.CT Cardiac Planning | Siemens Healthcare GmbH | 2017 | 1 |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K110366 | Syngo.CT Cardiac FunctionSummary page 2…n: Predicate Device Name FACerne FDA Clearance Date Number Siemens syngo.CT Cardiac K1 10366 12/04/2011 Function Siemens syngo.CT Vascular K1 12020 08/18/2011… | 2011 |
| * | K112020 | Syngo.CT Vascular AnalysisSummary page 2…Number Siemens syngo.CT Cardiac K1 10366 12/04/2011 Function Siemens syngo.CT Vascular K1 12020 08/18/2011 Analysis Siemens syngo Aortic Valve Guide K1 13027 11/22/2011 4. De… | 2011 |
| * | K113027 | Syngo Aortic Valveguide SoftwareSummary page 2…12/04/2011 Function Siemens syngo.CT Vascular K1 12020 08/18/2011 Analysis Siemens syngo Aortic Valve Guide K1 13027 11/22/2011 4. Device Description: syngo.CT-Cardiac Function is a dedicated application for cardiac and va… | 2011 |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 20 of the 90 ancestors have a recall of any class.
- Of its descendants, K183268 (Siemens Medical Solutions USA, Inc., 2019) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K110366.
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. 2012, 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 Function is an image analysis software package for evaluating CT images of the heart. Combining digital image processing and visualization tools (20, 3D and 4D display of dynamic data), evaluation tools (structural and functional analysis of heart chambers and valves, and analysis of myocardial tissue) and reporting tools, the software package is designed to support the physician in determining the functional and morphological parameters of the heart chambers, heart valves and confirming the presence or absence of physician-identified myocardial disease and evaluation, documentation and follow-up of any such finding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123585: Syngo, CT Cardiac Function.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123585
Report an extraction error
Are you the manufacturer?
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