510(k) · Cleared
Clearedsyngo. CT Single Source Dual Energy (twin beam)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc., Ultrasound DI · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 9, 2017 as substantially equivalent to K153220 (Siemens Medical Solutions USA, Inc., 2016) and 1 other predicate after a 79-day review. Its family tree reaches back 11 generations to 1996. 5 later devices descend from it.
- Decided
- Feb 9, 2017
- Review
- 79 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K954678 (1996). 62 ancestors in all, the oldest K837107 (1983). 5 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations between
- 3 generations backK133648 Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc. · 2014
- 2 generations backK150757 syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2015
- 1 generation backK153220 syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc. · 2016
- This deviceK163289 syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI · 2017
- Descendant · cites it directly · 4 of its ownK191468 syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK212889 Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK232155 syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK241757 syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2025
- Descendant · 5 generations on · 0 of its ownK251805 syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 10 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 9 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 8 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 7 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 6 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 5 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 4 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK133648 Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc. · 2014
- 2 generations backK150757 syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2015
- 1 generation backK153220 syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc. · 2016
- This deviceK163289 syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI · 2017
Most influential descendants
Showing 5 of 5 · See all- K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2019 · cites it directly4descendants
- K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2022 · 2 generations on3descendants
- K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2023 · 3 generations on2descendants
- K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2025 · 4 generations on1descendant
- K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −10 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −9 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −8 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −7 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −6 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −5 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −4 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K133648 | Syngo, CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −2 | K150757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2015 | — |
| −1 | K153220 | syngo.CT Single Source Dual Energy (Twin Beam) | Siemens Medical Solutions USA, Inc. | 2016 | — |
| 0 (this device) | K163289 | syngo. CT Single Source Dual Energy (twin beam) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2017 | — |
| +1 | K191468 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +2 | K212889 | Syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +3 | K232155 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2023 | — |
| +4 | K241757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025 | — |
| +5 | K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025 | — |
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 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K153220 | syngo.CT Single Source Dual Energy (Twin Beam)Summary page 4…ce Primary Predicate Device: Trade Name: syngo.CT Single Source Dual Energy (twin beam) 510(k) Number: K153220 Clearance Date: 02/19/2016 Siemens Medical Solutions USA, Inc.… | 2016 |
| * | K150757 | syngo.CT Dual EnergySummary page 5…no recalls for this device Secondary Predicate Device: Trade Name: syngo.CT Dual Energy 510(k) Number: K150757 Clearance Date: 08/11/2015 Classification Name: Computed Tomography X-ray System… | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191468 | syngo.CT Dual Energy | 2019 | 4 |
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 8 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 62 ancestors have a recall of any class.
- Of its descendants, K191468 (Siemens Medical Solutions USA, Inc., 2019) has gone furthest, with 4 descendants of its own.
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. 2017, 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 Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Twin Beam Single Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Single Source Dual Energy combines images acquired with low and high energy…
Read the full statement (196 words)
syngo.CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Twin Beam Single Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Single Source Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The functionality of the syngo.CT Single Source Dual Energy applications are as follows:
• Monoenergetic
• Bone Removal
• Liver VNC
• Lung Analysis
• Gout Evaluation
• Monoenergetic Plus
• Virtual Unenhanced
• Rho/Z
• Hard Plaques
• Kidney Stones*
*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163289: syngo. CT Single Source Dual Energy (twin beam).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163289
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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