510(k) · Cleared
ClearedAquilion ONE (TSX-308A/3) V1.5
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 Dec 23, 2024 as substantially equivalent to K232835 (Canon Medical Systems Corporation, 2024) after a 132-day review. Its family tree reaches back 19 generations to 1991. 2 later devices descend from it.
- Decided
- Dec 23, 2024
- Review
- 132 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K913770 (1991). 190 ancestors in all, the oldest K871859 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 15 generations between
- 3 generations backK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
- 2 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- 1 generation backK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
- This deviceK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
- Descendant · cites it directly · 0 of its ownK253596 Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · 2026
- Descendant · cites it directly · 0 of its ownK251645 Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B…Canon Medical Systems Corporation · 2025
Show all 19 generations
- Root · 19 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 18 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 17 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 16 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 15 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 14 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 13 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 12 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 11 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 10 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 9 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 8 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 7 generations backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- 6 generations backK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- 5 generations backK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- 4 generations backK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
- 3 generations backK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
- 2 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- 1 generation backK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
- This deviceK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −18 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −17 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −16 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −15 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −14 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −13 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −12 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −11 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −10 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −9 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| −8 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −7 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| −6 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| −5 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| −4 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
| −3 | K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2021 | — |
| −2 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software… | Canon Medical Systems Corporation | 2022 | — |
| −1 | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | 2024 | — |
| 0 (this device) | K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | 2024 | — |
| +1 | K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | 2026 | — |
| +1 | K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B… | Canon Medical Systems Corporation | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemSummary page 7…21 CFR System, X-ray, 308A/3) V1.4 with Medical Tomography K232835 April 2, 2024 §892.1750 Tomography, PIQE Reconstruction Sy… | 2024 |
| † | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package… | 2022 |
What descends from it? (2)
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 33 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 59 of the 190 ancestors have a recall of any class.
- Of its descendants, K253596 (Canon Medical Systems Corporation, 2026) has gone furthest, with 0 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. 2024, 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 (321 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 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.
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 images with less motion artifacts.
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/K242403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242403: Aquilion ONE (TSX-308A/3) V1.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242403
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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