510(k) · Cleared
ClearedAquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 3, 2023 as substantially equivalent to K201836 (Canon Medical Systems Corporation, 2021) after a 165-day review. Its family tree reaches back 6 generations to 2010. 3 later devices descend from it.
- Decided
- Mar 3, 2023
- Review
- 165 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K093891 (2010). 9 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK093891 Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation · 2010 · Recalled
- 5 generations backK121553 Aquilion RXLToshibamedical Systems Corporation · 2012 · Recalled
- 4 generations backK151833 Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015 · Recalled
- 3 generations backK153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016
- 2 generations backK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · Recalled
- 1 generation backK201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021
- This deviceK222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023
- Descendant · cites it directly · 2 of its ownK231281 Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK233334 Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation · 2023
- Descendant · 3 generations on · 0 of its ownK260078 Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation · 2026
Most influential descendants
Showing 3 of 3 · See all- K231281Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation · 2023 · cites it directly2descendants
- K233334Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation · 2023 · 2 generations on1descendant
- K260078Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K093891 | Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 | Toshibamedical Systems Corporation | 2010 | 1 |
| −5 | K121553 | Aquilion RXL | Toshibamedical Systems Corporation | 2012 | 1 |
| −4 | K151833 | Aquilion Lightning (TSX-035A/2, V7.0) | Toshibamedical Systems Corporation | 2015 | 1 |
| −3 | K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 | Toshibamedical Systems Corporation | 2016 | — |
| −2 | K170019 | Aquilion Lightning, TSX-036A/1, V8.4 | Toshibamedical Systems Corporation | 2017 | 1 |
| −1 | K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2021 | — |
| 0 (this device) | K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems Corporation | 2023 | — |
| +1 | K231281 | Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation | 2023 | — |
| +2 | K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems Corporation | 2023 | — |
| +3 | K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2026 | 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.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231281 | Aquilion Serve (TSX-307A/1) V1.3 | 2023 | 2 |
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 13 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 9 ancestors have a recall of any class.
- Of its descendants, K231281 (Canon Medical Systems Corporation, 2023) has gone furthest, with 2 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. 2023, 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 Serve 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. AiCE (Advanced Intelligent Clear-1Q Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222819 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222819: Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222819
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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