510(k) · Cleared
ClearedSyngo.CT Coronary Analysis
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 May 26, 2010 as substantially equivalent to K063762 (Siemens AG Medical Solutions, 2007) and 2 other predicates after an 82-day review. Its family tree reaches back 7 generations to 1997. 2 later devices descend from it.
- Decided
- May 26, 2010
- Review
- 82 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K971684 (1997). 29 ancestors in all, the oldest K913770 (1991). 2 later devices descend from it, 1 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 deviceK100637 Syngo.CT Coronary AnalysisSiemens AG Medical Solutions · 2010
- Descendant · cites it directly · 1 of its ownK173637 syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK220910 Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView 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) | K100637 | Syngo.CT Coronary Analysis | Siemens AG Medical Solutions | 2010 | — |
| +1 | K173637 | syngo.CT Coronary Analysis; syngo.CT Vascular Analysis | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K220910 | Medical image processing software | Hangzhou Deepwise & League of PHD Technology Co., Ltd. | 2022 | — |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K063762 | Syngo Circulation Software Package with Extended FunctionalitySummary page 2…devices: Manufacturer Product AM0Uk Clearance date 1.Siemens AG syngot Circulation K(063762 01/05/2007 2. Siemens AG syngo'.x K(092519 08/27/200 9 3.GE Medical Systems… | 2007 |
| * | K092519 | Syngo.XSummary page 2…e date 1.Siemens AG syngot Circulation K(063762 01/05/2007 2. Siemens AG syngo'.x K(092519 08/27/200 9 3.GE Medical Systems CardlQ Xpress 2.0 K(073138 02/26/2008 B. Device Descrip… | 2009 |
| * | K073138 | Cardiq Express Version 2.0Summary page 2…5/2007 2. Siemens AG syngo'.x K(092519 08/27/200 9 3.GE Medical Systems CardlQ Xpress 2.0 K(073138 02/26/2008 B. Device Description and Intended Use: Syngo.CT Coronary is an image analysis software package for evalua… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173637 | syngo.CT Coronary Analysis; syngo.CT Vascular Analysis | 2018 | 1 |
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 13 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 12 of the 29 ancestors have a recall of any class.
- Of its descendants, K173637 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 1 descendant 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. 2010, 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 Coronary is an image analysis software package for evaluating cardiac C'T 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), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque…
Read the full statement (130 words)
Syngo.CT Coronary is an image analysis software package for evaluating cardiac C'T 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), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion.
These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. 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/K100637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100637: Syngo.CT Coronary Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100637
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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