510(k) · Cleared
ClearedSyngo Single Source Dual Engery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 27, 2012 as substantially equivalent to K083524 (Siemens Medical Solutions USA, Inc., 2009) and 1 other predicate after a 97-day review. Its family tree reaches back 8 generations to 1996. 13 later devices descend from it.
- Decided
- Dec 27, 2012
- Review
- 97 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K954678 (1996). 62 ancestors in all, the oldest K837107 (1983). 13 later devices descend from it, 1 citing it directly.
- 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 deviceK122909 Syngo Single Source Dual EngerySiemens Medical Systems, Inc. · 2012
- Descendant · cites it directly · 12 of its ownK133677 Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2014
- Descendant · 2 generations on · 11 of its ownK150745 syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015
- Descendant · 3 generations on · 5 of its ownK173625 syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 4 generations on · 4 of its ownK192402 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK191468 syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2014 · cites it directly12descendants
- K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015 · 2 generations on11descendants
- K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018 · 3 generations on5descendants
- K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2019 · 4 generations on4descendants
- K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2019 · 3 generations on4descendants
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) | K122909 | Syngo Single Source Dual Engery | Siemens Medical Systems, Inc. | 2012 | — |
| +1 | K133677 | Syngo CT Single Source Dual Energy | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +2 | K150745 | syngo.CT Single Source Dual Energy | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +3 | K173625 | syngo.CT Clinical Extensions | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +4 | K192402 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +3 | K191468 | syngo.CT Dual Energy | 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 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K083524 | Syngo Dual Energy with Extended FunationallySummary page 2…FDA Clearance FDA Clearance Predicate Device Name Number Date syngo® Dual Energy with K083524 04/01/2009. extended functionality syngoo Volume Perfusion - CT K073373 12/1… | 2009 |
| * | K073373 | Syngo Volume Perfusion-CT BodySummary page 2…Date syngo® Dual Energy with K083524 04/01/2009. extended functionality syngoo Volume Perfusion - CT K073373 12/18/2007 Body _________ ________ 4. Device Description:… | 2007 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133677 | Syngo CT Single Source Dual Energy | 2014 | 12 |
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 16 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
- 10 of the 62 ancestors have a recall of any class.
- Of its descendants, K133677 (Siemens Medical Solutions USA, Inc., 2014) has gone furthest, with 12 descendants of its own.
- 6 other devices also cite its predicate K083524.
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?
syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. 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® Single Source Dual Energy applications are as follows:
* Gout Evaluation
* Monoenergetic
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122909: Syngo Single Source Dual Engery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122909
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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