510(k) · Cleared
ClearedAquilion LB, TSX-201A/3, V6.0
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 Mar 19, 2015 as substantially equivalent to K123500 (Toshibamedical Systems Corporation, 2013) after a 76-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Mar 19, 2015
- Review
- 76 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903701 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK903701 XpressToshiba America Medical Systems, In.C · 1990
- 5 generations backK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · Recalled
- 4 generations backK020385 CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002
- 3 generations backK022050 CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A…Toshiba America Medical Systems, In.C · 2002
- 2 generations backK050458 TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · Recalled
- 1 generation backK123500 Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013
- This deviceK150003 Aquilion LB, TSX-201A/3, V6.0Toshibamedical Systems Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903701 | Xpress | Toshiba America Medical Systems, In.C | 1990 | — |
| −5 | K982265 | Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 1998 | 3 |
| −4 | K020385 | CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 2002 | — |
| −3 | K022050 | CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion… | Toshiba America Medical Systems, In.C | 2002 | — |
| −2 | K050458 | TSX-201A Aquilion LB CT Scanner | Toshiba America Medical Systems, In.C | 2005 | 1 |
| −1 | K123500 | Aquilion LB Triton V4.91 | Toshibamedical Systems Corporation | 2013 | — |
| 0 (this device) | K150003 | Aquilion LB, TSX-201A/3, V6.0 | Toshibamedical Systems Corporation | 2015 | — |
Other ancestors 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? (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 |
|---|---|---|---|
| * | K123500 | Aquilion LB Triton V4.91Summary page 5…510(k) Number Clearance Date Aquilion LB Triton, Toshiba America K123500 May 2, 2013 TSX-201A/2, v4.91 Medical Systems 12. REASON FOR SUBMISSION: Modification o… | 2013 |
| † | K113715 | Lung Volume Analysis | 2012 |
| † | K133715 | Charlotte Claw Plate System | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K123500.
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. 2015, 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/K150003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150003: Aquilion LB, TSX-201A/3, V6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150003
Report an extraction error
Are you the manufacturer?
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