510(k) · Cleared
Recalled · Class II · 2019Aquilion Prime
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 Apr 6, 2012 after a 29-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 20 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 6, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 1
20 later devices descend from it, 1 citing it directly.
- This deviceK120710 Aquilion PrimeToshibamedical Systems Corporation · 2012
- Descendant · cites it directly · 19 of its ownK130645 Aquilion Prime, V5.00Toshibamedical Systems Corporation · 2013
- Descendant · 2 generations on · 18 of its ownK141741 Aquilion Prime, V6.00Toshibamedical Systems Corporation · 2014 · Recalled
- Descendant · 3 generations on · 9 of its ownK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · Recalled
- Descendant · 4 generations on · 4 of its ownK201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021
- Descendant · 3 generations on · 4 of its ownK173468 Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 2018 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K130645Aquilion Prime, V5.00Toshibamedical Systems Corporation · 2013 · cites it directly19descendants
- K141741Aquilion Prime, V6.00Toshibamedical Systems Corporation · 2014 · 2 generations on18descendants
- K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · 3 generations on9descendants
- K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021 · 4 generations on4descendants
- K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 2018 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120710 | Aquilion Prime | Toshibamedical Systems Corporation | 2012 | — |
| +1 | K130645 | Aquilion Prime, V5.00 | Toshibamedical Systems Corporation | 2013 | — |
| +2 | K141741 | Aquilion Prime, V6.00 | Toshibamedical Systems Corporation | 2014 | 2 |
| +3 | K170019 | Aquilion Lightning, TSX-036A/1, V8.4 | Toshibamedical Systems Corporation | 2017 | 1 |
| +4 | K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2021 | — |
| +3 | K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 | Toshibamedical Systems Corporation | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2025 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K100066 | FDA’s K100066 is Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130645 | Aquilion Prime, V5.00 | 2013 | 19 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2019 | Class II | Z-1723-2020 | Software design | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would… |
| May 8, 2015 | Class II | Z-0017-2016 | Radiation Control for Health and Safety Act | If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130645 (Toshibamedical Systems Corporation, 2013) has gone furthest, with 19 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. 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?
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120710: Aquilion Prime.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120710
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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