510(k) · Cleared
ClearedAquilion LB Triton V4.91
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 May 2, 2013 as substantially equivalent to K050458 (Toshiba America Medical Systems, In.C, 2005) and 1 other predicate after a 170-day review. Its family tree reaches back 5 generations to 1990. 4 later devices descend from it.
- Decided
- May 2, 2013
- Review
- 170 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903701 (1990). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK903701 XpressToshiba America Medical Systems, In.C · 1990
- 4 generations backK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · Recalled
- 3 generations backK020385 CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002
- 2 generations backK022050 CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A…Toshiba America Medical Systems, In.C · 2002
- 1 generation backK050458 TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · Recalled
- This deviceK123500 Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013
- Descendant · cites it directly · 2 of its ownK140651 Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK170490 Celesteion, PCA-9000A/3Toshibamedical Systems Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK181646 Celesteion, PCA-9000A/3, V6.5Canon Medical Systems Corporation · 2018
- Descendant · cites it directly · 0 of its ownK150003 Aquilion LB, TSX-201A/3, V6.0Toshibamedical Systems Corporation · 2015
Most influential descendants
Showing 4 of 4 · See all- K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · cites it directly2descendants
- K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation · 2017 · 2 generations on1descendant
- K181646Celesteion, PCA-9000A/3, V6.5Canon Medical Systems Corporation · 2018 · 3 generations on0descendants
- K150003Aquilion LB, TSX-201A/3, V6.0Toshibamedical Systems Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903701 | Xpress | Toshiba America Medical Systems, In.C | 1990 | — |
| −4 | K982265 | Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 1998 | 3 |
| −3 | K020385 | CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 2002 | — |
| −2 | K022050 | CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion… | Toshiba America Medical Systems, In.C | 2002 | — |
| −1 | K050458 | TSX-201A Aquilion LB CT Scanner | Toshiba America Medical Systems, In.C | 2005 | 1 |
| 0 (this device) | K123500 | Aquilion LB Triton V4.91 | Toshibamedical Systems Corporation | 2013 | — |
| +1 | K140651 | Celesteion, Pca-9000A/2 | Toshibamedical Systems Corporation | 2014 | 2 |
| +2 | K170490 | Celesteion, PCA-9000A/3 | Toshibamedical Systems Corporation | 2017 | — |
| +3 | K181646 | Celesteion, PCA-9000A/3, V6.5 | Canon Medical Systems Corporation | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K050458 | TSX-201A Aquilion LB CT ScannerSummary page 1…Product Marketed by 510(k) Number Clearance Date Aquilion LB CT Scanner TSX-201 A Toshiba America K050458 March 10, 2005 Medical Systems Aquilion ONE TSX-301A… | 2005 |
| * | K113466 | Aquilion OneSummary page 1…8 March 10, 2005 Medical Systems Aquilion ONE TSX-301A/2, w/4.74ER Toshiba America K113466 April 10, 2012 (Dose Reduction Technology) Medical Systems _______ _______… | 2012 |
What descends from it? (4)
2 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)
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 23 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K140651 (Toshibamedical Systems Corporation, 2014) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K050458.
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. 2013, 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/K123500 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123500: Aquilion LB Triton V4.91.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123500
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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