510(k) · Cleared
ClearedSyngo Circulation Software Package with Extended Functionality
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 Jan 5, 2007 as substantially equivalent to K052029 (Siemens AG Medical Solutions, 2005) and 2 other predicates after a 16-day review. Its family tree reaches back 4 generations to 1991. 1 of the 275 devices in its family, counting itself, has a Class I recall. 263 later devices descend from it.
- Decided
- Jan 5, 2007
- Review
- 16 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K913770 (1991). 11 ancestors in all. 263 later devices descend from it, 6 citing it directly. 1 of the 275 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 2 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 1 generation backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- This deviceK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- Descendant · cites it directly · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 2 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 3 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 2 generations on · 54 of its ownK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
Showing 5 of 263 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 263 · See all- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · cites it directly200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 2 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 2 generations on70descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 3 generations on63descendants
- K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010 · 2 generations on54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −2 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −1 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| +1 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +2 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +3 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +2 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 9 | 0 |
| 2016 | 8 | 0 |
| 2017 | 11 | 0 |
| 2018 | 18 | 0 |
| 2019 | 15 | 0 |
| 2020 | 25 | 0 |
| 2021 | 15 | 0 |
| 2022 | 24 | 0 |
| 2023 | 24 | 0 |
| 2024 | 22 | 0 |
| 2025 | 31 | 1 |
| 2026 | 30 | 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? (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 |
|---|---|---|---|
| * | K052029 | Syngo CirculationSummary page 2…software package: Manufacturer Product 510(k) Clearance date 1. Siemens AG syngo Circulation K052029 08/09/2005 2. Siemens AG syngo Multimodality K010938 06/26/2001… | 2005 |
| * | K010938 | Syngo Multimodality WorkstationSummary page 2…Clearance date 1. Siemens AG syngo Circulation K052029 08/09/2005 2. Siemens AG syngo Multimodality K010938 06/26/2001 Workstation (feature: Image Fusion)… | 2001 |
| * | K022013 | Lungcare CT Software PackageSummary page 2…26/2001 Workstation (feature: Image Fusion) 3. Siemens AG LungCARE CT K022013 07/16/2002 SW Package 8. Device Description and Intended Use: syngo Circ… | 2002 |
What descends from it? (263)
See all 2636 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091373 | Syngo Trued | 2009 | 200 |
| K110366 | Syngo.CT Cardiac Function | 2011 | 25 |
| K083327 | Syngocirculation Dynamicpet, Version 1.0 | 2009 | 20 |
| K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | 2009 | 19 |
| K101279 | CORRIDOR4DM V2010 Model: V2010 | 2010 | 12 |
| K100637 | Syngo.CT Coronary Analysis | 2010 | 2 |
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 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K091373 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 200 descendants of its own.
- 1 other device also cites its predicate K052029.
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. 2007, 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 Circulation is a self-contained image analysis software package for evaluating cardiac and pulmonary CTA, PET and SPECT volume data sets. syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, vessel aligned MPR, CPR, VRT, AngioView, hybrid visualization), evaluation tools (myocardial and volumetric analysis of the left ventricle, coronary tree segmentation, stenosis and…
Read the full statement (133 words)
syngo Circulation is a self-contained image analysis software package for evaluating cardiac and pulmonary CTA, PET and SPECT volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, vessel aligned MPR, CPR, VRT, AngioView, hybrid visualization), evaluation tools (myocardial and volumetric analysis of the left ventricle, coronary tree segmentation, stenosis and plaque evaluation) and reporting tools (lesion and pulmonary embolism (PE) 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, in evaluation of the hearts functional parameters and/or in confirming the presence or absence of physician identified filling defects, e.g. emboli, in the pulmonary arteries in addition to documentation and follow-up of any lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063762 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063762: Syngo Circulation Software Package with Extended Functionality.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063762
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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