510(k) · Cleared
Recalled · Class II · 2019Aquilion Premium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba Medical Systems Corporation, Japan · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 13, 2012 as substantially equivalent to K083282 (Toshiba America Medical Systems, In.C, 2008) after a 111-day review. Its family tree reaches back 4 generations to 2003. It has been recalled 2 times.
- Decided
- Jun 13, 2012
- Review
- 111 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K031469 (2003). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
- 3 generations backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
- 2 generations backK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
- 1 generation backK083282 Model TSX-301B Aquilion CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
- This deviceK120546 Aquilion PremiumToshiba Medical Systems Corporation, Japan · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031469 | Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 | Toshiba America Medical Systems, In.C | 2003 | 1 |
| −3 | K033418 | TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners | Toshiba America Medical Systems, In.C | 2003 | 2 |
| −2 | K051833 | TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner | Toshiba America Medical Systems, In.C | 2005 | — |
| −1 | K083282 | Model TSX-301B Aquilion CT System | Toshiba America Medical Systems, In.C | 2008 | 8 |
| 0 (this device) | K120546 | Aquilion Premium | Toshiba Medical Systems Corporation, Japan | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K083282 | Model TSX-301B Aquilion CT SystemSummary page 1…: JAK - System, Computed Tomography 9. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard 10. PREDICATE DEVICE: TSX-301B- K083282 11. REASON FOR SUBMISSION: Modification of a cleared device 12. DEVICE DESCRIPTION: The TSX-301B isa whole body CT sc… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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-1721-2020 | 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-0015-2016 | 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 6 ancestors have a recall of any class.
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, 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 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/K120546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120546: Aquilion Premium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120546
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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