510(k) · Cleared
Clearedsyngo.CT Myocardial Perfusion
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 Nov 2, 2015 as substantially equivalent to K092013 (Siemens AG Medical Solutions, 2009) after a 228-day review. Its family tree reaches back 8 generations to 1991. 1 later device descends from it.
- Decided
- Nov 2, 2015
- Review
- 228 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913770 (1991). 29 ancestors in all, the oldest K880965 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 4 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 3 generations backK052305 Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK073373 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2007
- 1 generation backK092013 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2009
- This deviceK150713 syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK162287 Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −4 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −3 | K052305 | Mri Soft Tissue Motion Correction Software VA10A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −2 | K073373 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2007 | — |
| −1 | K092013 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2009 | — |
| 0 (this device) | K150713 | syngo.CT Myocardial Perfusion | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +1 | K162287 | Synapse 3D Perfusion Analysis | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K092013 | Syngo Volume Perfusion-CT BodySummary page 5…3 syngo.CT Myocardial Perfusion 4. Legally Marketed Predicate Device Trade Name: syngo® Volume Perfusion CT Body 510(k)#: K092013 Clearance Date: July 17, 2009 Classification Name: Computed Tomography X-ray System Classificatio… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162287 | Synapse 3D Perfusion Analysis | 2017 | 0 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 29 ancestors have a recall of any class.
- Of its descendants, K162287 (Fujifilm Medical Systems U.S.A, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K092013.
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. 2015, 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?
The Siemens syngo.CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium.
The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.
It supports evaluation of regions of interest and the visual inspection of time attenuation curves.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150713: syngo.CT Myocardial Perfusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150713
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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