510(k) Report

510(k) · Cleared

Cleared

Aquilion ONE (TSX-308A/TSX-306A) V2.0

K253596510(k) TraditionalCleared May 20, 2026183-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year cleared 2021: 1 other ancestor2020: 1 other ancestor2019: 2 other ancestors2018: 1 other ancestor2015: 4 other ancestors2017: 1 other ancestor2012: 4 other ancestors2010: 2 other ancestors2008: 2 other ancestors2006: 8 other ancestors2016: 2 other ancestors2014: 1 other ancestor2013: 1 other ancestor2011: 2 other ancestors2009: 2 other ancestors2007: 4 other ancestors2005: 9 other ancestors2004: 13 other ancestors2001: 17 other ancestors2003: 15 other ancestors2002: 17 other ancestors2000: 12 other ancestors1999: 5 other ancestors1998: 8 other ancestors1997: 6 other ancestors1995: 7 other ancestors1994: 4 other ancestors1993: 4 other ancestors1996: 6 other ancestors1992: 2 other ancestors1989: 2 other ancestors1987: 1 other ancestor1991: 4 other ancestors1990: 1 other ancestorK913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK023003 · Imagechecker-CT Workstation · R2 Technology, Inc. · 2002×2: 2 generations cleared close together, K032748 (2003), K040305 (2004) K043333 · VITREA2, Version 3.7 Medical Image Processing System · Vital Images, Inc. · 2004 · recalledK052632 · VITREA2 Version 3.8 Medical Image Processing Software · Vital Images, Inc. · 2005 · recalledK061624 · Vitrea, Version 3.9 · Vital Images, Inc. · 2006 · recalledK071331 · Vitrea Version 4.0 · Vital Images, Inc. · 2007 · recalledK073156 · Qplaque MR · Medis Medical Imaging Systems BV · 2008K120636 · Synapse 3D Cardiac Tools · Fujifilm Medical System U.S.A., Inc. · 2012K171222 · Vitrea Software Toshiba Package; VSTP-001A · Toshibamedical Systems Corporation · 2017K173088 · Vitrea Software Toshiba Package VSTP-001A · Toshibamedical Systems Corporation · 2018K183013 · Vitrea Software Package, VSTP-001A · Canon Medical Systems Corporation · 2018K192923 · Vitrea Software Package · Canon Medical Systems Corporation · 2020K203312 · Vitrea Software Package, VSTP-001A · Canon Medical Systems Corporation · 2021K213504 · Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A · Canon Medical Systems Corporation · 2022K232835 · Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System · Canon Medical Systems Corporation · 2024K242403 · Aquilion ONE (TSX-308A/3) V1.5 · Canon Medical Systems Corporation · 20241990200020102020
Other ancestors, by generation 4 generations back: 1 other ancestor5 generations back: 1 other ancestor6 generations back: 1 other ancestor7 generations back: 3 other ancestors8 generations back: 7 other ancestors9 generations back: 17 other ancestors10 generations back: 34 other ancestors11 generations back: 40 other ancestors12 generations back: 31 other ancestors13 generations back: 16 other ancestors14 generations back: 15 other ancestors15 generations back: 3 other ancestors16 generations back: 2 other ancestors K242403 · Aquilion ONE (TSX-308A/3) V1.5 · Canon Medical Systems Corporation · 2024K232835 · Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System · Canon Medical Systems Corporation · 2024K213504 · Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A · Canon Medical Systems Corporation · 2022K203312 · Vitrea Software Package, VSTP-001A · Canon Medical Systems Corporation · 2021K192923 · Vitrea Software Package · Canon Medical Systems Corporation · 2020K183013 · Vitrea Software Package, VSTP-001A · Canon Medical Systems Corporation · 2018K173088 · Vitrea Software Toshiba Package VSTP-001A · Toshibamedical Systems Corporation · 2018K171222 · Vitrea Software Toshiba Package; VSTP-001A · Toshibamedical Systems Corporation · 2017K120636 · Synapse 3D Cardiac Tools · Fujifilm Medical System U.S.A., Inc. · 2012K073156 · Qplaque MR · Medis Medical Imaging Systems BV · 2008K071331 · Vitrea Version 4.0 · Vital Images, Inc. · 2007 · recalledK061624 · Vitrea, Version 3.9 · Vital Images, Inc. · 2006 · recalledK052632 · VITREA2 Version 3.8 Medical Image Processing Software · Vital Images, Inc. · 2005 · recalledK043333 · VITREA2, Version 3.7 Medical Image Processing System · Vital Images, Inc. · 2004 · recalledK040305 · VITREA2 Version 3.5 · Vital Images, Inc. · 2004K032748 · VITREA2, Version 3.4 Medical Image Processing Software · Vital Images, Inc. · 2003 · recalledK023003 · Imagechecker-CT Workstation · R2 Technology, Inc. · 2002K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991−20−15−10−50
  1. Root · 20 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 16 generations between
  3. 3 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
  4. 2 generations backK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
  5. 1 generation backK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
  6. This deviceK253596 Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · 2026
Show all 20 generations
  1. Root · 20 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 19 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. 18 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
  4. 17 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
  5. 16 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
  6. 15 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
  7. 14 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
  8. 13 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
  9. 12 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
  10. 11 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
  11. 10 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
  12. 9 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
  13. 8 generations backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
  14. 7 generations backK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
  15. 6 generations backK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
  16. 5 generations backK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
  17. 4 generations backK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
  18. 3 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
  19. 2 generations backK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
  20. 1 generation backK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
  21. 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

GenerationNumberDeviceApplicantDecidedRecalls
−20K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−19K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
−18K020483Advantage Workstation 4.1GE Medical Systems20022
−17K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002—
−16K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20032
−15K040305VITREA2 Version 3.5Vital Images, Inc.2004—
−14K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041
−13K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20052
−12K061624Vitrea, Version 3.9Vital Images, Inc.20061
−11K071331Vitrea Version 4.0Vital Images, Inc.20071
−10K073156Qplaque MRMedis Medical Imaging Systems BV2008—
−9K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.2012—
−8K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation2017—
−7K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation2018—
−6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation2018—
−5K192923Vitrea Software PackageCanon Medical Systems Corporation2020—
−4K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation2021—
−3K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software…Canon Medical Systems Corporation2022—
−2K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation2024—
−1K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation2024—
0 (this device)K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198920
199010
199140
199220
199340
199440
199570
199660
199760
199880
199950
2000120
2001170
2002170
2003150
2004130
200590
200680
200740
200820
200920
201020
201120
201240
201310
201410
201540
201620
201710
201810
201920
202010
202110
FIG. 1 — Lineage of K253596, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K242403Aquilion ONE (TSX-308A/3) V1.5
Summary 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…
Canon Medical Systems Corporation2024—

Also cleared against K242403: 1 other device →

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 devices

JAK 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

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

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.

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