510(k) · Cleared
ClearedSyngo.CT Vascular Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medi Cal Solutions, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 18, 2011 as substantially equivalent to K043469 (Siemens AG Medical Solutions, 2005) and 3 other predicates after a 35-day review. Its family tree reaches back 8 generations to 1996. 1 of the 184 devices in its family, counting itself, has a Class I recall. 99 later devices descend from it.
- Decided
- Aug 18, 2011
- Review
- 35 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K954678 (1996). 84 ancestors in all, the oldest K837107 (1983). 99 later devices descend from it, 6 citing it directly. 1 of the 184 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 6 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 5 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 4 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 3 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 2 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 1 generation backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- This deviceK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · cites it directly · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 2 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
- Descendant · 3 generations on · 23 of its ownK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- Descendant · 4 generations on · 21 of its ownK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 5 generations on · 14 of its ownK182904 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…4 generations on · 2025
Most influential descendants
Showing 5 of 99 · See all- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · cites it directly63descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 2 generations on46descendants
- K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017 · 3 generations on23descendants
- K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018 · 4 generations on21descendants
- K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −7 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −6 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −5 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −4 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −3 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −2 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −1 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| 0 (this device) | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +1 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +2 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| +3 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +4 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +5 | K182904 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 8 | 0 |
| 2020 | 12 | 0 |
| 2021 | 4 | 0 |
| 2022 | 9 | 0 |
| 2023 | 14 | 0 |
| 2024 | 11 | 0 |
| 2025 | 12 | 1 |
| 2026 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | K043469 | Syngo Inspace 4DSummary page 2…owing devices: Manufacturer Product 510(k) Clearance date 1. Siemens AG syngo® Inspace 4D K043469 02/03/2005 2. Siemens AG syngo®.x K092519 08/27/2009 3. Siemens AG… | 2005 |
| * | K092519 | Syngo.XSummary page 2…rance date 1. Siemens AG syngo® Inspace 4D K043469 02/03/2005 2. Siemens AG syngo®.x K092519 08/27/2009 3. Siemens AG syngo® Dual Energy with K083524 04/01/2009… | 2009 |
| * | K083524 | Syngo Dual Energy with Extended FunationallySummary page 2…02/03/2005 2. Siemens AG syngo®.x K092519 08/27/2009 3. Siemens AG syngo® Dual Energy with K083524 04/01/2009 extended functionality 4. TeraRecon Inc. Aquarius Intuition Workflow… | 2009 |
| * | K061214 | Aquariusaps ServerSummary page 2…l Energy with K083524 04/01/2009 extended functionality 4. TeraRecon Inc. Aquarius Intuition Workflow K061214 05/15/2006 Platform 510(k) re-submission for SIEMENS' syngo.cT Vascular Analysis (CT-QvA)… | 2006 |
What descends from it? (99)
See all 996 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 · 4 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 8 companies; a new generation was cleared every 2.4 years on median.
- 18 of the 84 ancestors have a recall of any class.
- Of its descendants, K123920 (Siemens AG Medical Solutions, 2013) has gone furthest, with 63 descendants of its own.
- 4 other devices also cite its predicate K043469.
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. 2011, 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?
syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools…
Read the full statement (142 words)
syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images.
Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified lesions in blood vessels and evaluation, documentation and follow-up of any such lesion.
These visualization/processing/evaluation tools allow for characterization of vascular lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112020: Syngo.CT Vascular Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112020
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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