510(k) · Cleared
ClearedAquilion ServeSP (TSX-307B) V2.0
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 13, 2026 as substantially equivalent to K233334 (Canon Medical Systems Corporation, 2023) after a 60-day review. Its family tree reaches back 9 generations to 2010.
- Decided
- Mar 13, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K093891 (2010). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK093891 Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation · 2010 · Recalled
- 5 generations between
- 3 generations backK222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023
- 2 generations backK231281 Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation · 2023
- 1 generation backK233334 Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation · 2023
- This deviceK260078 Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation · 2026
Show all 9 generations
- Root · 9 generations backK093891 Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation · 2010 · Recalled
- 8 generations backK121553 Aquilion RXLToshibamedical Systems Corporation · 2012 · Recalled
- 7 generations backK151833 Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015 · Recalled
- 6 generations backK153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016
- 5 generations backK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · Recalled
- 4 generations backK201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021
- 3 generations backK222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023
- 2 generations backK231281 Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation · 2023
- 1 generation backK233334 Aquilion Serve SP (TSX-307B/1) V1.3Canon Medical Systems Corporation · 2023
- This deviceK260078 Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K093891 | Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 | Toshibamedical Systems Corporation | 2010 | 1 |
| −8 | K121553 | Aquilion RXL | Toshibamedical Systems Corporation | 2012 | 1 |
| −7 | K151833 | Aquilion Lightning (TSX-035A/2, V7.0) | Toshibamedical Systems Corporation | 2015 | 1 |
| −6 | K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 | Toshibamedical Systems Corporation | 2016 | — |
| −5 | K170019 | Aquilion Lightning, TSX-036A/1, V8.4 | Toshibamedical Systems Corporation | 2017 | 1 |
| −4 | K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2021 | — |
| −3 | K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems Corporation | 2023 | — |
| −2 | K231281 | Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation | 2023 | — |
| −1 | K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems Corporation | 2023 | — |
| 0 (this device) | 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 |
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?
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 16 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 12 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. 2026, 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 SP 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‐IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep…
Read the full statement (178 words)
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head.
The Aquilion Serve SP 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‐IQ 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.
PIQE is a Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Neural Network (DCNN), it is possible to achieve both spatial resolution improvement and noise reduction for cardiac, abdomen, pelvis, and lung applications, in comparison to FBP and hybrid iterative reconstruction.
CLEAR Motion is a Deep Learning Reconstruction (DLR) method designed to reduce motion artifacts. A Deep Convolutional Neural Network (DCNN) is used to estimate the patient's motion. This information is used in the reconstruction process to obtain lung images with less motion artifacts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260078: Aquilion ServeSP (TSX-307B) V2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260078
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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