510(k) · Cleared
ClearedSyngo Perfusion-CT
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 23, 2003 as substantially equivalent to K982536 (Siemens Corp., 1998) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1988. 1 of the 200 devices in its family, counting itself, has a Class I recall. 194 later devices descend from it.
- Decided
- Dec 23, 2003
- Review
- 13 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K880965 (1988). 5 ancestors in all. 194 later devices descend from it, 3 citing it directly. 1 of the 200 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK880965 Somatom PlusSiemens Medical Solutions USA, Inc. · 1988
- 1 generation backK982536 Perfusion CT (Computed Tomography) Software PackageSiemens Corp. · 1998
- This deviceK033832 Syngo Perfusion-CTSiemens AG Medical Solutions · 2003
- Descendant · cites it directly · 192 of its ownK050867 Syngo Body Perfusion-CTSiemens AG · 2005
- Descendant · 2 generations on · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
- Descendant · 3 generations on · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
- Descendant · 4 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- Descendant · 5 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
Showing 5 of 194 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 194 · See all- K050867Syngo Body Perfusion-CTSiemens AG · 2005 · cites it directly192descendants
- K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · 2 generations on169descendants
- K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · 3 generations on168descendants
- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 4 generations on117descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 5 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880965 | Somatom Plus | Siemens Medical Solutions USA, Inc. | 1988 | — |
| −1 | K982536 | Perfusion CT (Computed Tomography) Software Package | Siemens Corp. | 1998 | — |
| 0 (this device) | K033832 | Syngo Perfusion-CT | Siemens AG Medical Solutions | 2003 | — |
| +1 | K050867 | Syngo Body Perfusion-CT | Siemens AG | 2005 | — |
| +2 | K062351 | Syngo Dual Energy | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +3 | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
| +4 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +5 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 0 |
| 2021 | 8 | 0 |
| 2022 | 16 | 0 |
| 2023 | 16 | 0 |
| 2024 | 16 | 0 |
| 2025 | 19 | 1 |
| 2026 | 16 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K982536 | Perfusion CT (Computed Tomography) Software PackageSummary page 2…tware package Manufacturer Product 510(k) Clearance date 1. Siemens syngo Perfusion-CT K982536 Nov. 24, 1998 2. General Electric CT Perfusion 2 K010042 Jan. 30, 2001 8.… | 1998 |
| * | K010042 | CT Perfusion 2Summary page 2…Clearance date 1. Siemens syngo Perfusion-CT K982536 Nov. 24, 1998 2. General Electric CT Perfusion 2 K010042 Jan. 30, 2001 8. Device Description and Intended Use: Syngo Perfusion-CT is a post-processing softw… | 2001 |
What descends from it? (194)
See all 1943 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K050867 (Siemens AG, 2005) has gone furthest, with 192 descendants of its own.
- 1 other device also cites its predicate K982536.
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.
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 Perfusion-CT 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) and vascular permeability (blood brain barrier disturbances) from sets of images reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of…
Read the full statement (200 words)
The Siemens syngo Perfusion-CT 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) and vascular permeability (blood brain barrier disturbances) from sets of images reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.
One potential 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).
Syngo Perfusion-CT is sensitive in identifying the areas of decreased perfusion which indicates the occurrence of acute stroke, during the first 6 hours after onset of symptoms.
A second potential application is the visualization of blood-brain-barrier disturbances in brain tumors. A modified Patlak approach is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033832: Syngo Perfusion-CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033832
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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