510(k) · Cleared
ClearedSyngo Dual Energy with Extended Funationally
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 1, 2009 as substantially equivalent to K073003 (Siemens Medi Cal Solutions, Inc., 2008) and 2 other predicates after a 124-day review. Its family tree reaches back 7 generations to 1996. 1 of the 165 devices in its family, counting itself, has a Class I recall. 117 later devices descend from it.
- Decided
- Apr 1, 2009
- Review
- 124 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K954678 (1996). 47 ancestors in all, the oldest K837107 (1983). 117 later devices descend from it, 7 citing it directly. 1 of the 165 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 3 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 2 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 1 generation backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- This deviceK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 2 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 3 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
- Descendant · 4 generations on · 23 of its ownK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- Descendant · 5 generations on · 21 of its ownK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…5 generations on · 2025
Most influential descendants
Showing 5 of 117 · See all- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · cites it directly99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 2 generations on63descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 3 generations on46descendants
- K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017 · 4 generations on23descendants
- K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −3 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −2 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −1 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| 0 (this device) | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +2 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +3 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| +4 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +5 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | — |
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 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 9 | 0 |
| 2020 | 13 | 0 |
| 2021 | 4 | 0 |
| 2022 | 10 | 0 |
| 2023 | 15 | 0 |
| 2024 | 11 | 0 |
| 2025 | 14 | 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? (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 |
|---|---|---|---|
| * | K073003 | Syngo Dual Energy with Extended FunctionallySummary page 2…Manufacturer Product510(k) Clearance date 1. Siemens syngo Dual Energy K073003 02/07/2008 2. Siemens syngo Oncology K071310 06/08/2007… | 2008 |
| * | K071310 | Syngo CT Oncology Software PackageSummary page 2…1. Siemens syngo Dual Energy K073003 02/07/2008 2. Siemens syngo Oncology K071310 06/08/2007 3. Siemens SOMATOM DR I K837107 03/09/1983… | 2007 |
| * | K837107 | Somatom Dri X-Ray CT ScannerSummary page 2…2. Siemens syngo Oncology K071310 06/08/2007 3. Siemens SOMATOM DR I K837107 03/09/1983 8. Device Description and Intended Use: Device Name: syngoe Dual Energy with extended functionalit… | 1983 |
What descends from it? (117)
See all 1177 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112020 | Syngo.CT Vascular Analysis | 2011 | 99 |
| K133648 | Syngo, CT Dual Energy | 2014 | 16 |
| K150757 | syngo.CT Dual Energy | 2015 | 13 |
| K122909 | Syngo Single Source Dual Engery | 2012 | 13 |
| K133677 | Syngo CT Single Source Dual Energy | 2014 | 12 |
| K132813 | Dual Energy System Package | 2014 | 2 |
| K132902 | Syngo Dual Energy Software Package | 2014 | 0 |
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 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 47 ancestors have a recall of any class.
- Of its descendants, K112020 (Siemens Medi Cal Solutions, Inc., 2011) has gone furthest, with 99 descendants of its own.
- 1 other device also cites its predicate K073003.
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. 2009, 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® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined…
Read the full statement (137 words)
Syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures.
The functionality of the syngo® Dual Energy applications are as follows:
* Lung Nodules
* Xenon (Lung Ventilation)
* Monoenergetic
* Brain Haemorrhage
* Gout Evaluation
* Lung Vessels
* Heart PBV
* Dual Energy Bone Removal
* Cartilage, Tendon, Ligament
* Lung Perfusion
* Liver
* Hard Plaques in Vessels
* Kidney Stones
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083524: Syngo Dual Energy with Extended Funationally.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083524
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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