510(k) · Cleared
ClearedDual Energy System Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 6, 2014 as substantially equivalent to K120833 (Ge Medical Systems, LLC, 2012) and 1 other predicate after a 150-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Feb 6, 2014
- Review
- 150 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K954678 (1996). 54 ancestors in all, the oldest K837107 (1983). 2 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 deviceK132813 Dual Energy System PackageToshibamedical Systems Corporation · 2014
- Descendant · cites it directly · 0 of its ownK182601 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- Descendant · cites it directly · 0 of its ownK161157 Vitrea CT Dual Energy Image ViewVital Images, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView 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) | K132813 | Dual Energy System Package | Toshibamedical Systems Corporation | 2014 | — |
| +1 | K182601 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| +1 | K161157 | Vitrea CT Dual Energy Image View | Vital Images, Inc. | 2016 | — |
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 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120833 | Discovery CT750 HDSummary page 2…TE DEVICES: Product Marketed by 510(k) Number Clearance Date Discovery CT 750HD GE Healthcare K120833 June 12, 2012 Brilliance Dual Energy Philips Medical Systems, 006 ue2,20 Option… | 2012 |
| Kept off the family tree | K006002 | Brilliance Dual Energy Option Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K083524 | Syngo Dual Energy with Extended FunationallySummary page 2…006 ue2,20 Option Inc.' K006Jue2,09 syngo Dual Energy with Siemens Medical Solutions K083524 April 1, 2009 extended functionality IUSA, Inc. 12. DEVICE DESCRIPTION: Dual Energy System Package, CSDP-OOIA… | 2009 |
What descends from it? (2)
2 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 8 companies; a new generation was cleared every 2.5 years on median.
- 12 of the 54 ancestors have a recall of any class.
- Of its descendants, K182601 (Canon Medical Systems Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K120833.
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?
The Dual Energy System allows the system to acquire two CT images of the same anatomical location using distinct tube voltages and/or tube currents during two tube rotations. The x-ray dose will be the sum of the dose of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in x-ray attenuation between these…
Read the full statement (168 words)
The Dual Energy System allows the system to acquire two CT images of the same anatomical location using distinct tube voltages and/or tube currents during two tube rotations. The x-ray dose will be the sum of the dose of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in x-ray attenuation between these distinct energies.
This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials.
The visualization of the differentiation between uric acid and non-uric acid stones greater than 3mm and the visualization of uric acid presence within surrounding anatomical structures is provided with the Dual Energy system. When used by a qualified physician, a potential application is to determine the course of treatment.
Performance of this device may be affected by body size and motion artifacts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132813 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132813: Dual Energy System Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132813
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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