510(k) · Cleared
ClearedAquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
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 24, 2021 as substantially equivalent to K192828 (Canon Medical Systems Corporation, 2020) after a 142-day review. Its family tree reaches back 11 generations to 2012. 7 later devices descend from it.
- Decided
- Mar 24, 2021
- Review
- 142 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K113466 (2012). 12 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK113466 Aquilion OneToshiba Medical Systems Coporation, Japan · 2012 · Recalled
- 7 generations between
- 3 generations backK183046 Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation · 2019
- 2 generations backK192188 Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation · 2019
- 1 generation backK192828 Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation · 2020
- This deviceK203225 Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation · 2021
- Descendant · cites it directly · 6 of its ownK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- Descendant · 2 generations on · 3 of its ownK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
- Descendant · 3 generations on · 2 of its ownK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
- Descendant · 2 generations on · 1 of its ownK223336 Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation · 2023
- Descendant · 4 generations on · 0 of its ownK253596 Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · 2026
Show all 11 generations
- Root · 11 generations backK113466 Aquilion OneToshiba Medical Systems Coporation, Japan · 2012 · Recalled
- 10 generations backK122109 Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C · 2012 · Recalled
- 9 generations backK132222 Aquilion One Vision, V6.0Toshibamedical Systems Corporation · 2013 · Recalled
- 8 generations backK133497 Aquilion One VisionToshibamedical Systems Corporation · 2014
- 7 generations backK142465 Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · Recalled
- 6 generations backK151673 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · Recalled
- 5 generations backK161009 Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4Toshibamedical Systems Corporation · 2016
- 4 generations backK170177 Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation · 2017 · Recalled
- 3 generations backK183046 Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation · 2019
- 2 generations backK192188 Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation · 2019
- 1 generation backK192828 Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation · 2020
- This deviceK203225 Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation · 2022 · cites it directly6descendants
- K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024 · 2 generations on3descendants
- K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024 · 3 generations on2descendants
- K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation · 2023 · 2 generations on1descendant
- K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K113466 | Aquilion One | Toshiba Medical Systems Coporation, Japan | 2012 | 3 |
| −10 | K122109 | Aquilion One Vision, V4.90 | Toshiba America Medical Systems, In.C | 2012 | 1 |
| −9 | K132222 | Aquilion One Vision, V6.0 | Toshibamedical Systems Corporation | 2013 | 2 |
| −8 | K133497 | Aquilion One Vision | Toshibamedical Systems Corporation | 2014 | — |
| −7 | K142465 | Aquilion ONE Vision, v7.0 | Toshibamedical Systems Corporation | 2015 | 1 |
| −6 | K151673 | Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) | Toshibamedical Systems Corporation | 2015 | 1 |
| −5 | K161009 | Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 | Toshibamedical Systems Corporation | 2016 | — |
| −4 | K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 | Toshibamedical Systems Corporation | 2017 | 1 |
| −3 | K183046 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE | Canon Medical Systems Corporation | 2019 | — |
| −2 | K192188 | Aquilion ONE (TSX-306A/3) V10.0 | Canon Medical Systems Corporation | 2019 | — |
| −1 | K192828 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System | Canon Medical Systems Corporation | 2020 | — |
| 0 (this device) | K203225 | Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System | Canon Medical Systems Corporation | 2021 | — |
| +1 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software… | Canon Medical Systems Corporation | 2022 | — |
| +2 | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | 2024 | — |
| +3 | K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | 2024 | — |
| +2 | K223336 | Vitrea Software Package, VSTP-002A | Canon Medical Systems Corporation | 2023 | — |
| +4 | K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192828 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemSummary page 5…306A/3) V10.0 with 21 CFR System, X‐ray, Medical Tomography K192828 02/13/2020 Spectral Imaging §892.1750 Tomography, Sy… | 2020 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package… | 2022 | 6 |
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 9 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 6 of the 12 ancestors have a recall of any class.
- Of its descendants, K213504 (Canon Medical Systems Corporation, 2022) has gone furthest, with 6 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. 2021, 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 ONE 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…
Read the full statement (226 words)
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 ONE 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.
FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
AiCE 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, brain, inner ear and extremities applications.
The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The X-ray dose will be the sum of the dose at each respective tube voltage and current in a rotation.
Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies.
When used by a qualified physician, a potential application is to determine the course of treatment.
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/K203225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203225: Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203225
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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