510(k) · Cleared
ClearedSyngo Volume Perfusion-CT Body
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 Jul 17, 2009 as substantially equivalent to K073373 (Siemens AG Medical Solutions, 2007) and 1 other predicate after an 11-day review. Its family tree reaches back 7 generations to 1991. 6 later devices descend from it.
- Decided
- Jul 17, 2009
- Review
- 11 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913770 (1991). 28 ancestors in all, the oldest K880965 (1988). 6 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 3 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 2 generations backK052305 Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc. · 2005
- 1 generation backK073373 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2007
- This deviceK092013 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2009
- Descendant · cites it directly · 2 of its ownK151212 Ziostation2Qi Imaging, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK181892 Ziostation2Ziosoft, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK150713 syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK200315 Ziostation2Ziosoft, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK162287 Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151212Ziostation2Qi Imaging, LLC · 2015 · cites it directly2descendants
- K181892Ziostation2Ziosoft, Inc. · 2018 · 2 generations on1descendant
- K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc. · 2015 · cites it directly1descendant
- K200315Ziostation2Ziosoft, Inc. · 2020 · 3 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −3 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −2 | K052305 | Mri Soft Tissue Motion Correction Software VA10A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −1 | K073373 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2007 | — |
| 0 (this device) | K092013 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2009 | — |
| +1 | K151212 | Ziostation2 | Qi Imaging, LLC | 2015 | — |
| +2 | K181892 | Ziostation2 | Ziosoft, Inc. | 2018 | — |
| +1 | K150713 | syngo.CT Myocardial Perfusion | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +3 | K200315 | Ziostation2 | Ziosoft, Inc. | 2020 | — |
| +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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K073373 | Syngo Volume Perfusion-CT BodySummary page 2…learance date 1. Siemens AG syngo Volume Perfusion CT Body K073373 Dec 18, 2007 2. Siemens AG syngo Volume Perfusion CT Neuro K073238 Jan 03, 2008 8. Device Des… | 2007 |
| * | K073238 | Syngo Volume Perfusion-CT NeuroSummary page 2…date 1. Siemens AG syngo Volume Perfusion CT Body K073373 Dec 18, 2007 2. Siemens AG syngo Volume Perfusion CT Neuro K073238 Jan 03, 2008 8. Device Description and Intended Use: syngo® Volume Perfusion-CT Body software package with exten… | 2008 |
What descends from it? (6)
4 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)
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 18 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 28 ancestors have a recall of any class.
- Of its descendants, K151212 (Qi Imaging, LLC, 2015) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K073373.
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. 2009, 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 Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It…
Read the full statement (118 words)
The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.
The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.
A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092013: Syngo Volume Perfusion-CT Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092013
Report an extraction error
Are you the manufacturer?
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