510(k) · Cleared
ClearedSyngo Body Perfusion-CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 14, 2005 as substantially equivalent to K033832 (Siemens AG Medical Solutions, 2003) and 1 other predicate after an 8-day review. Its family tree reaches back 3 generations to 1988. 1 of the 199 devices in its family, counting itself, has a Class I recall. 192 later devices descend from it.
- Decided
- Apr 14, 2005
- Review
- 8 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K880965 (1988). 6 ancestors in all. 192 later devices descend from it, 3 citing it directly. 1 of the 199 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK880965 Somatom PlusSiemens Medical Solutions USA, Inc. · 1988
- 2 generations backK982536 Perfusion CT (Computed Tomography) Software PackageSiemens Corp. · 1998
- 1 generation backK033832 Syngo Perfusion-CTSiemens AG Medical Solutions · 2003
- This deviceK050867 Syngo Body Perfusion-CTSiemens AG · 2005
- Descendant · cites it directly · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
- Descendant · 2 generations on · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
- Descendant · 3 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- Descendant · 4 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 5 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 192 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 192 · See all- K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · cites it directly169descendants
- K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · 2 generations on168descendants
- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 3 generations on117descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 4 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 5 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K880965 | Somatom Plus | Siemens Medical Solutions USA, Inc. | 1988 | — |
| −2 | K982536 | Perfusion CT (Computed Tomography) Software Package | Siemens Corp. | 1998 | — |
| −1 | K033832 | Syngo Perfusion-CT | Siemens AG Medical Solutions | 2003 | — |
| 0 (this device) | K050867 | Syngo Body Perfusion-CT | Siemens AG | 2005 | — |
| +1 | K062351 | Syngo Dual Energy | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +2 | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
| +3 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +4 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +5 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
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 |
|---|---|---|
| 2006 | 1 | 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 |
|---|---|---|---|
| * | K033832 | Syngo Perfusion-CTSummary page 2…software package Manufacturer Product 510(k) Clearance date 1. Siemens syngo Perfusion-CT K033832 Dec. 23, 2003 2. General Electric CT Perfusion 2 K010042 Jan. 30, 2001 8. Device… | 2003 |
| * | K010042 | CT Perfusion 2Summary page 2…Clearance date 1. Siemens syngo Perfusion-CT K033832 Dec. 23, 2003 2. General Electric CT Perfusion 2 K010042 Jan. 30, 2001 8. Device Description and Intended Use: Syngo Body Perfusion-CT is a post-processing softwar… | 2001 |
What descends from it? (192)
See all 1923 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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K062351 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 169 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.
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 Body Perfusion-CT 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…
Read the full statement (111 words)
The Siemens syngo Body Perfusion-CT 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/K050867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050867: Syngo Body Perfusion-CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050867
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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