510(k) · Cleared
Recalled · Class II · 2011Aquilion One TSX-301A/2 Computed Tomography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 2, 2007 as substantially equivalent to K063189 (Toshiba America Medical Systems, In.C, 2006) after a 15-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 2, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063189 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK063189 TSX-301A, Aquilion One CT SystemToshiba America Medical Systems, In.C · 2006
- This deviceK072606 Aquilion One TSX-301A/2 Computed Tomography SystemToshiba America Medical Systems, In.C · 2007
- Descendant · cites it directly · 1 of its ownK083282 Model TSX-301B Aquilion CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK120546 Aquilion PremiumToshiba Medical Systems Corporation, Japan · 2012 · Recalled
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 |
|---|---|---|---|---|---|
| −1 | K063189 | TSX-301A, Aquilion One CT System | Toshiba America Medical Systems, In.C | 2006 | — |
| 0 (this device) | K072606 | Aquilion One TSX-301A/2 Computed Tomography System | Toshiba America Medical Systems, In.C | 2007 | — |
| +1 | K083282 | Model TSX-301B Aquilion CT System | Toshiba America Medical Systems, In.C | 2008 | 8 |
| +2 | K120546 | Aquilion Premium | Toshiba Medical Systems Corporation, Japan | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K063189 | TSX-301A, Aquilion One CT SystemSummary page 1…(714)730-5000 Establishment Registration Number: 2020563 Device Proprietary Name: TSX-301A/i, Aquilion ONE CT System, k063189 TSX-101A/h, /I Aquilion 32/64 SP CT System, k051833 Comm… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083282 | Model TSX-301B Aquilion CT System | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2011 | Not classified | Z-3196-2011 | Software design | Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray… |
| Jul 13, 2009 | Class II | Z-2282-2012 | Software design | 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch… |
| Feb 3, 2009 | Not classified | Z-2339-2010 | Software design | ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB. |
| May 13, 2008 | Class II | Z-2468-2012 | Software design | The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2007, 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 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 then 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/K072606 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072606: Aquilion One TSX-301A/2 Computed Tomography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072606
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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