510(k) · Cleared
Recalled · Class II · 2019Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2
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 18, 2010 after a 335-day review. The FDA summary names no predicate by number. 15 later devices descend from it. It has been recalled once.
- Decided
- Nov 18, 2010
- Review
- 335 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK093891 Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation · 2010
- Descendant · cites it directly · 13 of its ownK121553 Aquilion RXLToshibamedical Systems Corporation · 2012 · Recalled
- Descendant · 2 generations on · 11 of its ownK151833 Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 3 generations on · 10 of its ownK153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016
- Descendant · 4 generations on · 9 of its ownK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · Recalled
- Descendant · 5 generations on · 4 of its ownK201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K121553Aquilion RXLToshibamedical Systems Corporation · 2012 · cites it directly13descendants
- K151833Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015 · 2 generations on11descendants
- K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016 · 3 generations on10descendants
- K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · 4 generations on9descendants
- K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093891 | Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 | Toshibamedical Systems Corporation | 2010 | — |
| +1 | K121553 | Aquilion RXL | Toshibamedical Systems Corporation | 2012 | 1 |
| +2 | K151833 | Aquilion Lightning (TSX-035A/2, V7.0) | Toshibamedical Systems Corporation | 2015 | 1 |
| +3 | K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 | Toshibamedical Systems Corporation | 2016 | — |
| +4 | K170019 | Aquilion Lightning, TSX-036A/1, V8.4 | Toshibamedical Systems Corporation | 2017 | 1 |
| +5 | K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (15)
See all 152 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 |
|---|---|---|---|---|
| Mar 25, 2019 | Class II | Z-1720-2020 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121553 (Toshibamedical Systems Corporation, 2012) has gone furthest, with 13 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. 2010, 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; with the capability of imaging 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 then be used to perform specialized studies, using indicated software/hardware of the whole organ by a…
Read the full statement (126 words)
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head; with the capability of imaging 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 then be used to perform specialized studies, using indicated software/hardware of the whole organ by a trained and qualified physician.
The Dual Energy System has been designed to analyze the composition of body materials. The system can load two CT images scanned with two different tube voltages and analyze the composition of the target materials by using the energy dependence of the attenuation coefficients of materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093891: Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093891
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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