510(k) · Cleared
ClearedSyngo Circulation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 9, 2005 as substantially equivalent to K041267 (General Electric Medical Systems, 2004) after a 13-day review. Its family tree reaches back 3 generations to 2000. 1 of the 302 devices in its family, counting itself, has a Class I recall. 296 later devices descend from it.
- Decided
- Aug 9, 2005
- Review
- 13 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000315 (2000). 5 ancestors in all. 296 later devices descend from it, 2 citing it directly. 1 of the 302 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
- 2 generations backK013422 Cardiq FunctionGE Medical Systems · 2001
- 1 generation backK041267 Cardiq Analysis IiiGeneral Electric Medical Systems · 2004
- This deviceK052029 Syngo CirculationSiemens AG Medical Solutions · 2005
- Descendant · cites it directly · 263 of its ownK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
- Descendant · 2 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
Showing 5 of 296 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 296 · See all- K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007 · cites it directly263descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
- K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · cites it directly168descendants
- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 2 generations on117descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 3 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000315 | Ventricular Analysis Toolkit Option | GE Medical Systems | 2000 | — |
| −2 | K013422 | Cardiq Function | GE Medical Systems | 2001 | — |
| −1 | K041267 | Cardiq Analysis Iii | General Electric Medical Systems | 2004 | — |
| 0 (this device) | K052029 | Syngo Circulation | Siemens AG Medical Solutions | 2005 | — |
| +1 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| +2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
| +2 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 8 | 0 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 13 | 0 |
| 2018 | 19 | 0 |
| 2019 | 18 | 0 |
| 2020 | 27 | 0 |
| 2021 | 16 | 0 |
| 2022 | 27 | 0 |
| 2023 | 27 | 0 |
| 2024 | 23 | 0 |
| 2025 | 33 | 1 |
| 2026 | 31 | 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? (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 |
|---|---|---|---|
| * | K041267 | Cardiq Analysis IiiSummary page 2…software package: Manufacturer Product 510(k) Clearance date 1. General Electric CardlQ Analysis III K041267 05/27/2004 8. Device Description and Intended Use: syngo Circulation is a self-contained image analysis soft… | 2004 |
What descends from it? (296)
See all 2962 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K063762 (Siemens AG Medical Solutions, 2007) has gone furthest, with 263 descendants of its own.
- 6 other devices also cite its predicate K041267.
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.
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 Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets. syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including…
Read the full statement (147 words)
syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence or absence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions.
These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052029: Syngo Circulation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052029
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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