510(k) · Cleared
ClearedSyngo, CT Dual Energy
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 Jul 7, 2014 as substantially equivalent to K083524 (Siemens Medical Solutions USA, Inc., 2009) and 1 other predicate after a 222-day review. Its family tree reaches back 8 generations to 1996. 16 later devices descend from it.
- Decided
- Jul 7, 2014
- Review
- 222 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K954678 (1996). 48 ancestors in all, the oldest K837107 (1983). 16 later devices descend from it, 2 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 deviceK133648 Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc. · 2014
- Descendant · cites it directly · 13 of its ownK150757 syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2015
- Descendant · cites it directly · 11 of its ownK150745 syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK153220 syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc. · 2016
- Descendant · 2 generations on · 5 of its ownK173625 syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK163289 syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc. · 2015 · cites it directly13descendants
- K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015 · cites it directly11descendants
- K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc. · 2016 · 2 generations on6descendants
- K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on5descendants
- K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI · 2017 · 2 generations on5descendants
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) | K133648 | Syngo, CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +1 | K150757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +1 | K150745 | syngo.CT Single Source Dual Energy | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +2 | K153220 | syngo.CT Single Source Dual Energy (Twin Beam) | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +2 | K173625 | syngo.CT Clinical Extensions | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K163289 | syngo. CT Single Source Dual Energy (twin beam) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2017 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 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…11 Product Code: JAK Trade Name: syngo® Dual Energy with extended functionality 510(k)#: K083524 Clearance Date: April 01, 2009 Classification Name: System, X-Ray, Tomography, Computed… | 2009 |
| * | K837107 | Somatom Dri X-Ray CT ScannerSummary page 2…90JAK Legally Marketed Predicate Devices Trade Name: SOMATOM DRI X-Ray Scanner CT System 510(k)#: K837107 Clearance Date: March 09, 1983 Classification Name: System, X-Ray, Tomography, Computed… | 1983 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 48 ancestors have a recall of any class.
- Of its descendants, K150757 (Siemens Medical Solutions USA, Inc., 2015) has gone furthest, with 13 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. 2014, 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 Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images…
Read the full statement (182 words)
syngo.CT Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information.
The functionality of the syngo.CT Dual Energy applications is as follows:
Monoenergetic; Lung Perfusion; Brain Hemorrhage; Liver VNC; Gout Evaluation; Monoenergetic Plus; Lung Vessels; Virtual Unenhanced; Heart PBV; Bone Marrow; Bone Removal; 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 as stated in the FDA summary.
https://510kreport.com/device/K133648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133648: Syngo, CT Dual Energy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133648
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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