510(k) · Cleared
ClearedSyngo Volume Perfusion-CT Neuro
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 3, 2008 as substantially equivalent to K033832 (Siemens AG Medical Solutions, 2003) and 2 other predicates after a 48-day review. Its family tree reaches back 4 generations to 1988. 19 later devices descend from it.
- Decided
- Jan 3, 2008
- Review
- 48 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K880965 (1988). 8 ancestors in all. 19 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK880965 Somatom PlusSiemens Medical Solutions USA, Inc. · 1988
- 3 generations backK982536 Perfusion CT (Computed Tomography) Software PackageSiemens Corp. · 1998
- 2 generations backK033832 Syngo Perfusion-CTSiemens AG Medical Solutions · 2003
- 1 generation backK050867 Syngo Body Perfusion-CTSiemens AG · 2005
- This deviceK073238 Syngo Volume Perfusion-CT NeuroSiemens AG Medical Solutions · 2008
- Descendant · cites it directly · 8 of its ownK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- Descendant · cites it directly · 6 of its ownK092013 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2009
- Descendant · 2 generations on · 5 of its ownK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- Descendant · 4 generations on · 3 of its ownK212896 Visible Patient SuiteVisible Patient, Sas · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K121213VitreaadvancedVital Images, Inc. · 2012 · cites it directly8descendants
- K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2009 · cites it directly6descendants
- K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · 2 generations on5descendants
- K151988Visible Patient SuiteVisible Patient, Sas · 2015 · 3 generations on4descendants
- K212896Visible Patient SuiteVisible Patient, Sas · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K880965 | Somatom Plus | Siemens Medical Solutions USA, Inc. | 1988 | — |
| −3 | K982536 | Perfusion CT (Computed Tomography) Software Package | Siemens Corp. | 1998 | — |
| −2 | K033832 | Syngo Perfusion-CT | Siemens AG Medical Solutions | 2003 | — |
| −1 | K050867 | Syngo Body Perfusion-CT | Siemens AG | 2005 | — |
| 0 (this device) | K073238 | Syngo Volume Perfusion-CT Neuro | Siemens AG Medical Solutions | 2008 | — |
| +1 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 1 |
| +1 | K092013 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2009 | — |
| +2 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| +3 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| +4 | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K033832 | Syngo Perfusion-CTSummary page 2…ailable software package Manufacturer Product 510(k) Clearance date 1. Siemens syngo Perfusion-CT K033832 12/23/2003 2. Siemens syngo Perf. CT Body K050867 04/14/2005 3. General Electr… | 2003 |
| * | K050867 | Syngo Body Perfusion-CTSummary page 2…k) Clearance date 1. Siemens syngo Perfusion-CT K033832 12/23/2003 2. Siemens syngo Perf. CT Body K050867 04/14/2005 3. General Electric CT Perfusion 4 K052839 03/10/2006 8. Device Descript… | 2005 |
| * | K052839 | CT Perfusion 4Summary page 2…K033832 12/23/2003 2. Siemens syngo Perf. CT Body K050867 04/14/2005 3. General Electric CT Perfusion 4 K052839 03/10/2006 8. Device Description and Intended Use: syngo® Volume Perfusion-CT Neuro is a post-processing so… | 2006 |
What descends from it? (19)
See all 194 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 20 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K121213 (Vital Images, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K033832.
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. 2008, 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 Neuro software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak), mean transit time (MTT), and vascular permeability (blood brain barrier disturbances) from sets of images or volumes reconstructed from continuously acquired CT data after the injection of contrast…
Read the full statement (213 words)
The Siemens syngo® Volume Perfusion-CT Neuro software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak), mean transit time (MTT), and vascular permeability (blood brain barrier disturbances) from sets of images or volumes reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves.
One clinical application is to visualize the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for CBF and CBV, higher for time to peak and MTT).
Syngo® Volume Perfusion-CT Neuro supports the physician in identifying areas of decreased perfusion which indicate the occurrence of acute stroke during the first 6 hours after onset of symptoms.
A second application is the visualization of the permeability. It is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability can display blood brain barrier disturbances and thus may improve the differential diagnosis of brain tumors and be helpful intherapy monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073238: Syngo Volume Perfusion-CT Neuro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073238
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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