510(k) · Cleared
Recalled · 2012Model TSX-301B Aquilion CT 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 Dec 12, 2008 as substantially equivalent to K072606 (Toshiba America Medical Systems, In.C, 2007) and 1 other predicate after a 35-day review. Its family tree reaches back 3 generations to 2003. 1 later device descends from it. It has been recalled 8 times.
- Decided
- Dec 12, 2008
- Review
- 35 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 3 generations to K031469 (2003). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 2 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
- 1 generation backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
- This deviceK083282 Model TSX-301B Aquilion CT SystemToshiba America Medical Systems, In.C · 2008
- Descendant · cites it directly · 0 of its ownK120546 Aquilion PremiumToshiba Medical Systems Corporation, Japan · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K120546Aquilion PremiumToshiba Medical Systems Corporation, Japan · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031469 | Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 | Toshiba America Medical Systems, In.C | 2003 | 1 |
| −2 | K033418 | TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners | Toshiba America Medical Systems, In.C | 2003 | 2 |
| −1 | K051833 | TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner | Toshiba America Medical Systems, In.C | 2005 | — |
| 0 (this device) | K083282 | Model TSX-301B Aquilion CT System | Toshiba America Medical Systems, In.C | 2008 | — |
| +1 | K120546 | Aquilion Premium | Toshiba Medical Systems Corporation, Japan | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K072606 | Aquilion One TSX-301A/2 Computed Tomography SystemSummary page 1…Subchapter J, Federal Diagnostic X-ray Equipment Standard Predicate Device(s): TSX-301A12, Aquilion ONE CT System, k072606 TSX-lI lA/h, /I Aquilion 32/64 SP CT System, kOS 1833… | 2007 |
| * | K051833 | TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120546 | Aquilion Premium | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2012 | Not classified | Z-1034-2012 | Software design | The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One. |
| Jan 3, 2012 | Not classified | Z-1035-2012 | Software design | The recall was initiated because Toshiba has confirmed that their is a potential software issue for the TSX-301A Aquilon One and the TSX-301B Aquilon One. |
| Jun 22, 2011 | Not classified | Z-3195-2011 | 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… |
| Jan 7, 2011 | Not classified | Z-2895-2011 | Software design | Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may be broken due to… |
| Jan 7, 2011 | Not classified | Z-2896-2011 | Software design | Toshiba America Medical Systems (TAMS) is initiating a field correction for the TSX-301A and TSX-301B: Aquilion 64 System, X-Ray, Tomography because communication between reconstruction units in the system console may be broken due to… |
| Sep 7, 2010 | Not classified | Z-1257-2011 | Software design | Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV. This results in a pre-scan expected dose that is approximately 10%… |
| Jul 22, 2010 | Not classified | Z-1665-2011 | Software design | Toshiba America Medical Systems (TAMS) has found that communication may be cut off in the Aquilion ONE/ Premium Systems, owing to the failure of a part used in the console. |
| Jan 7, 2010 | Not classified | Z-0907-2010 | Device Design | When W-Volume is performed in Prospective CTA or Target CTA studies with ECG gating, unnecessary intervals may be set before starting the volume scan. As a result, scanning cannot be performed at the appropriate timing of constant… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K120546 (Toshiba Medical Systems Corporation, Japan, 2012) has gone furthest, with 0 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. 2008, 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 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/K083282 · printed Nov 3, 2026
Cite this page
510(k) Report. “K083282: Model TSX-301B Aquilion CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K083282
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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