510(k) · Cleared
Recalled · Class II · 2014Aquilion One Vision, V6.0
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 Nov 7, 2013 as substantially equivalent to K122109 (Toshiba America Medical Systems, In.C, 2012) after a 113-day review. Its family tree reaches back 2 generations to 2012. 31 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 7, 2013
- Review
- 113 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K113466 (2012). 31 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK113466 Aquilion OneToshiba Medical Systems Coporation, Japan · 2012 · Recalled
- 1 generation backK122109 Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C · 2012 · Recalled
- This deviceK132222 Aquilion One Vision, V6.0Toshibamedical Systems Corporation · 2013
- Descendant · cites it directly · 23 of its ownK133497 Aquilion One VisionToshibamedical Systems Corporation · 2014
- Descendant · cites it directly · 22 of its ownK142465 Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 2 generations on · 13 of its ownK151673 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 2 generations on · 13 of its ownK151091 Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation · 2015
- Descendant · 3 generations on · 12 of its ownK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K133497Aquilion One VisionToshibamedical Systems Corporation · 2014 · cites it directly23descendants
- K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · cites it directly22descendants
- K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · 2 generations on13descendants
- K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation · 2015 · 2 generations on13descendants
- K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K113466 | Aquilion One | Toshiba Medical Systems Coporation, Japan | 2012 | 3 |
| −1 | K122109 | Aquilion One Vision, V4.90 | Toshiba America Medical Systems, In.C | 2012 | 1 |
| 0 (this device) | K132222 | Aquilion One Vision, V6.0 | Toshibamedical Systems Corporation | 2013 | — |
| +1 | K133497 | Aquilion One Vision | Toshibamedical Systems Corporation | 2014 | — |
| +1 | K142465 | Aquilion ONE Vision, v7.0 | Toshibamedical Systems Corporation | 2015 | 1 |
| +2 | K151673 | Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) | Toshibamedical Systems Corporation | 2015 | 1 |
| +2 | K151091 | Vitrea Software Toshiba Package, VSTP-001A | Toshibamedical Systems Corporation | 2015 | — |
| +3 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K122109 | Aquilion One Vision, V4.90Summary page 1…Marketed by 510(k) Number Clearance Date Aquilion ONE Vision, Toshiba America K122109 September 21, 2012 TSX-301C/1, v4 90 Medical Systems… | 2012 |
What descends from it? (31)
See all 313 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2014 | Class II | Z-0471-2015 | Software design | Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume… |
| Dec 11, 2013 | Class II | Z-0972-2014 | Other | Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K133497 (Toshibamedical Systems Corporation, 2014) has gone furthest, with 23 descendants of its own.
- 4 other devices also cite its predicate K122109.
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. 2013, 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?
This device is indicated ta acquire and display cross sectional volumes of the whole
body, to include the head, with the capability to image whole organs in a single rotation.
Whole organs include but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These
volume sets can be used to perform specialized studies, using indicated
software/hardware, of the whole organ by a trained and qualified physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132222 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132222: Aquilion One Vision, V6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132222
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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