510(k) · Cleared
ClearedSyngo CT Dynamic Angio
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 Apr 13, 2012 as substantially equivalent to K062673 (Siemens AG Medical Solutions, 2006) and 2 other predicates after a 71-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Apr 13, 2012
- Review
- 71 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K913770 (1991). 38 ancestors in all, the oldest K880965 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 4 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
- 3 generations backK052305 Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK073373 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2007
- 1 generation backK092013 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2009
- This deviceK120331 Syngo CT Dynamic AngioSiemens AG Medical Solutions · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −4 | K043216 | Cadstream Version 4.0 | Confirma, Inc. | 2005 | — |
| −3 | K052305 | Mri Soft Tissue Motion Correction Software VA10A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −2 | K073373 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2007 | — |
| −1 | K092013 | Syngo Volume Perfusion-CT Body | Siemens AG Medical Solutions | 2009 | — |
| 0 (this device) | K120331 | Syngo CT Dynamic Angio | Siemens AG Medical Solutions | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K062673 | Modification to Syngo Inspace 4DSummary page 3…the following devices: Manufacturer Product 510k Clearance date 1.Siemens AG syngo® Inspace 4D K062673 2209/2006 2. Siemens AG syngo® Volume Perfusion CT- Body K092013 17/07/2009 3. Siemens AG syngo®… | 2006 |
| * | K092013 | Syngo Volume Perfusion-CT BodySummary page 3…510k Clearance date 1.Siemens AG syngo® Inspace 4D K062673 2209/2006 2. Siemens AG syngo® Volume Perfusion CT- Body K092013 17/07/2009 3. Siemens AG syngo® Volume Perfusion CT- Neuro K073238 03/01/2008 9. Summary of Technologi… | 2009 |
| * | K073238 | Syngo Volume Perfusion-CT NeuroSummary page 3…K062673 2209/2006 2. Siemens AG syngo® Volume Perfusion CT- Body K092013 17/07/2009 3. Siemens AG syngo® Volume Perfusion CT- Neuro K073238 03/01/2008 9. Summary of Technological Characteristics of the Principle Device as Compared with the Predicate Devices… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 7 of the 38 ancestors have a recall of any class.
- 2 other devices also cite its predicate K062673.
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. 2012, 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 syngo.CT Dynamic Angio software package has been designed to evaluate CT data which has been continuously acquired with computed tomography (CT) imaging systems. Contrast enhanced CT images are used to visualize the flow of contrast from the arteries to the veins. syngo.CT Dynamic Angio can be used to assist the physician in the diagnosis of blood vessels and it supports in the evaluation of regions of interest, the visual inspection of time…
Read the full statement (125 words)
The syngo.CT Dynamic Angio software package has been designed to evaluate CT data which has been continuously acquired with computed tomography (CT) imaging systems. Contrast enhanced CT images are used to visualize the flow of contrast from the arteries to the veins.
syngo.CT Dynamic Angio can be used to assist the physician in the diagnosis of blood vessels and it supports in the evaluation of regions of interest, the visual inspection of time attenuation curves, and the creation of specific CT volumes, for example, arterial or venous phase. It will aid in the inspection of diseases which affect the vessel system, for example, vessel stenosis, collateral or late filling of vessels, vascular malformations, control of stent graft extravasation, or in the evaluation of tumor vascularization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120331: Syngo CT Dynamic Angio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120331
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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