510(k) · Cleared
ClearedSyngo Dual Energy with Extended Functionally
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 Feb 7, 2008 as substantially equivalent to K062351 (Siemens Medical Solutions USA, Inc., 2006) and 3 other predicates after a 106-day review. Its family tree reaches back 6 generations to 1995. 1 of the 196 devices in its family, counting itself, has a Class I recall. 168 later devices descend from it.
- Decided
- Feb 7, 2008
- Review
- 106 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K954355 (1995). 27 ancestors in all, the oldest K880965 (1988). 168 later devices descend from it, 2 citing it directly. 1 of the 196 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 5 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 4 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 3 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 2 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 1 generation backK062673 Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006
- This deviceK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
- Descendant · cites it directly · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 3 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · cites it directly · 54 of its ownK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- Descendant · 4 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
Showing 5 of 168 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 168 · See all- K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · cites it directly117descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 2 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 3 generations on63descendants
- K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010 · cites it directly54descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 4 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −5 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −4 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −3 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −2 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −1 | K062673 | Modification to Syngo Inspace 4D | Siemens AG Medical Solutions | 2006 | — |
| 0 (this device) | K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | 2008 | — |
| +1 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +3 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +1 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +4 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 11 | 0 |
| 2019 | 12 | 0 |
| 2020 | 18 | 0 |
| 2021 | 7 | 0 |
| 2022 | 16 | 0 |
| 2023 | 16 | 0 |
| 2024 | 15 | 0 |
| 2025 | 17 | 1 |
| 2026 | 15 | 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 |
|---|---|---|---|
| * | K062351 | Syngo Dual EnergySummary page 2…devices: Manufacturer Product 510(k) Clearance date 1. Siemens syngo Dual Energy K062351 10/05/2006 2. Siemens syngo Circulation K052029 08/09/2005 3. Sieme… | 2006 |
| * | K052029 | Syngo CirculationSummary page 2…Clearance date 1. Siemens syngo Dual Energy K062351 10/05/2006 2. Siemens syngo Circulation K052029 08/09/2005 3. Siemens syngo InSpace 4D K071513 06/26/2007 4. Sieme… | 2005 |
| * | K071513 | Inspace 4D Software Package with Extended FunctionalitySummary page 2…10/05/2006 2. Siemens syngo Circulation K052029 08/09/2005 3. Siemens syngo InSpace 4D K071513 06/26/2007 4. Siemens syngo InSpace 4D K062673 09/22/2006 8. Device… | 2007 |
| * | K062673 | Modification to Syngo Inspace 4DSummary page 2…08/09/2005 3. Siemens syngo InSpace 4D K071513 06/26/2007 4. Siemens syngo InSpace 4D K062673 09/22/2006 8. Device Description and Intended Use: Syngo® Dual Energy is designed to operate with Siemens… | 2006 |
What descends from it? (168)
See all 1682 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 · 6 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 6 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K083524 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 117 descendants of its own.
- 1 other device also cites its predicate K062351.
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. 2008, 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 to visualize and analyze information about anatomical and pathological structures.
The functionality of the syngo® Dual Energy has been extended with additional applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073003: Syngo Dual Energy with Extended Functionally.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073003
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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