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 Dec 18, 2007 as substantially equivalent to K050867 (Siemens AG, 2005) and 2 other predicates after a 15-day review. Its family tree reaches back 6 generations to 1991. 33 later devices descend from it.
- Decided
- Dec 18, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K913770 (1991). 26 ancestors in all, the oldest K880965 (1988). 33 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 1 generation backK052305 Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc. · 2005
- This deviceK073373 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2007
- Descendant · cites it directly · 13 of its ownK122909 Syngo Single Source Dual EngerySiemens Medical Systems, Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK133677 Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2014
- Descendant · 3 generations on · 11 of its ownK150745 syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015
- Descendant · cites it directly · 10 of its ownK090504 CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation · 2009
- Descendant · 2 generations on · 8 of its ownK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc. · 2012 · cites it directly13descendants
- K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2014 · 2 generations on12descendants
- K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015 · 3 generations on11descendants
- K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation · 2009 · cites it directly10descendants
- K121213VitreaadvancedVital Images, Inc. · 2012 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −1 | K052305 | Mri Soft Tissue Motion Correction Software VA10A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| 0 (this device) | K073373 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2007 | — |
| +1 | K122909 | Syngo Single Source Dual Engery | Siemens Medical Systems, Inc. | 2012 | — |
| +2 | K133677 | Syngo CT Single Source Dual Energy | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +3 | K150745 | syngo.CT Single Source Dual Energy | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +1 | K090504 | CSBP-001A Body Perfusion System | Toshibamedical Systems Corporation | 2009 | — |
| +2 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K050867 | Syngo Body Perfusion-CTSummary page 2…Manufacturer Product 510(k Clearance date 1. Siemens syngo Body Pert. CT K050867 Apr. 14. 2005 2. General Electric CT Perfusion 4 K052839 Mar. 10. 2006 3. Sieme… | 2005 |
| * | K052839 | CT Perfusion 4Summary page 2…1. Siemens syngo Body Pert. CT K050867 Apr. 14. 2005 2. General Electric CT Perfusion 4 K052839 Mar. 10. 2006 3. Siemens MR[ Soft Tissue Motion K052305 Sep. 08. 2005… | 2006 |
| * | K052305 | Mri Soft Tissue Motion Correction Software VA10ASummary page 2…2. General Electric CT Perfusion 4 K052839 Mar. 10. 2006 3. Siemens MR[ Soft Tissue Motion K052305 Sep. 08. 2005 Correction Software 8. Device Description and Intended Use: s5yf… | 2005 |
What descends from it? (33)
See all 334 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 16 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K122909 (Siemens Medical Systems, Inc., 2012) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K050867.
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?
The Siemens syngo Volume Perfusion-CT Body software package has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume 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…
Read the full statement (112 words)
The Siemens syngo Volume Perfusion-CT Body software package has been designed to
evaluate perfusion of organs and tumors.
The software can calculate blood flow, blood volume 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/K073373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073373: 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/K073373
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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