510(k) · Cleared
ClearedAquilion ONE (TSX-308A/TSX-306A) 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 May 20, 2026 as substantially equivalent to K242403 (Canon Medical Systems Corporation, 2024) after a 183-day review. Its family tree reaches back 20 generations to 1991.
- Decided
- May 20, 2026
- Review
- 183 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K913770 (1991). 191 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 20 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 16 generations between
- 3 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- 2 generations backK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
- 1 generation backK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
- This deviceK253596 Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · 2026
Show all 20 generations
- Root · 20 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 19 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 18 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 17 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 16 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 15 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 14 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 13 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 12 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 11 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 10 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 9 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 8 generations backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- 7 generations backK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- 6 generations backK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- 5 generations backK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
- 4 generations backK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
- 3 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- 2 generations backK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
- 1 generation backK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
- This deviceK253596 Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −19 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −18 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −17 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −16 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −15 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −14 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −13 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −12 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −11 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −10 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| −9 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −8 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| −7 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| −6 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| −5 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
| −4 | K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2021 | — |
| −3 | 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 | — |
| −1 | K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | 2024 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 17 | 0 |
| 2002 | 17 | 0 |
| 2003 | 15 | 0 |
| 2004 | 13 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K242403 | Aquilion ONE (TSX-308A/3) V1.5Summary page 7…by Number Name Code Number Date Aquilion ONE Canon 21 CFR Computed JAK K242403 12/23/2024 (TSX-308A) Medical §892.1750 Tomography V1.5 Systems USA… | 2024 |
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 35 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 59 of the 191 ancestors have a recall of any class.
- 1 other device also cites its predicate K242403.
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, 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 (462 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, extremities, head, and inner ear applications.
The spectral imaging system utilizes two scan modes: spectral imaging scan and dual energy scan.
The spectral imaging scan 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.
The dual energy scan, utilized for brain imaging, allows the system to acquire two CT images of the same anatomical location using distinct tube voltages and/or tube currents during two tube rotations. The X-ray dose will be the sum of the dose of each tube rotation at its respective tube voltage and current. 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.
This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials.
Performance of dual energy scan may be affected by body size and motion artifacts.
When used by a qualified physician, a potential application is to determine the course of treatment.
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 and 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 and cardiac images with less motion artifacts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253596 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253596: Aquilion ONE (TSX-308A/TSX-306A) V2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253596
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026