510(k) · Cleared
Recalled · Class II · 2019Syngo.CT Cardiac Function
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 Apr 12, 2011 as substantially equivalent to K063762 (Siemens AG Medical Solutions, 2007) and 3 other predicates after a 64-day review. Its family tree reaches back 7 generations to 1997. 25 later devices descend from it. It has been recalled once.
- Decided
- Apr 12, 2011
- Review
- 64 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 7 generations to K971684 (1997). 30 ancestors in all, the oldest K913770 (1991). 25 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 5 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 4 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 3 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 2 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 1 generation backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- This deviceK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011
- Descendant · cites it directly · 14 of its ownK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- Descendant · 2 generations on · 11 of its ownK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- Descendant · 3 generations on · 9 of its ownK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- Descendant · 4 generations on · 6 of its ownK230223 iCAC DeviceBunkerhill, Inc. · 2023
- Descendant · cites it directly · 6 of its ownK112531 Vitrea CT Myocardial AnalysisVital Images, Inc. · 2011
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012 · cites it directly14descendants
- K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019 · 2 generations on11descendants
- K210085HealthCCSngZebra Medical Vision, Ltd. · 2021 · 3 generations on9descendants
- K230223iCAC DeviceBunkerhill, Inc. · 2023 · 4 generations on6descendants
- K112531Vitrea CT Myocardial AnalysisVital Images, Inc. · 2011 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −6 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −5 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −4 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −3 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −2 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −1 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| 0 (this device) | K110366 | Syngo.CT Cardiac Function | Siemens AG | 2011 | — |
| +1 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +2 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +3 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| +4 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
| +1 | K112531 | Vitrea CT Myocardial Analysis | Vital Images, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K063762 | Syngo Circulation Software Package with Extended FunctionalitySummary page 2…vices: Manufacturer Product 610(k) Clearance date 1. Siemens AG Syngoe Circulation K063762 01/05/2007 2. Siemens AG syngo®.x K092519 08/27/2009 4. GE Medical Systems… | 2007 |
| * | K092519 | Syngo.XSummary page 2…ce date 1. Siemens AG Syngoe Circulation K063762 01/05/2007 2. Siemens AG syngo®.x K092519 08/27/2009 4. GE Medical Systems CardlQ Function Xpress K073153 02/26/2008 5. GE Medical Systems… | 2009 |
| * | K073153 | Cardiq Function XpressSummary page 2…1/05/2007 2. Siemens AG syngo®.x K092519 08/27/2009 4. GE Medical Systems CardlQ Function Xpress K073153 02/26/2008 5. GE Medical Systems CardIQ Xpress 2.0 K073138 02/26/2008 510(k) submission… | 2008 |
| * | K073138 | Cardiq Express Version 2.0Summary page 2…8/27/2009 4. GE Medical Systems CardlQ Function Xpress K073153 02/26/2008 5. GE Medical Systems CardIQ Xpress 2.0 K073138 02/26/2008 510(k) submission for SIEMENS' syngo.CT Cardiac Function (CT-CrA) Page 2 of 4 === Page 3… | 2008 |
What descends from it? (25)
See all 254 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2019 | Class II | Z-1112-2019 | 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 14 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 12 of the 30 ancestors have a recall of any class.
- Of its descendants, K123585 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K063762.
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. 2011, 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 cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation…
Read the full statement (152 words)
Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the Software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding.
These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110366: Syngo.CT Cardiac Function.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110366
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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