510(k) Report

510(k) · Cleared

Cleared

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

K232835510(k) TraditionalCleared Apr 2, 2024201-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 Apr 2, 2024 as substantially equivalent to K213504 (Canon Medical Systems Corporation, 2022) after a 201-day review. Its family tree reaches back 18 generations to 1991. 3 later devices descend from it.

Decided
Apr 2, 2024
Review
201 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 18 generations to K913770 (1991). 189 ancestors in all, the oldest K871859 (1987). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, 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 ancestor2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK913770 · 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 · 20221990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 3 other ancestors6 generations back: 7 other ancestors7 generations back: 17 other ancestors8 generations back: 34 other ancestors9 generations back: 40 other ancestors10 generations back: 31 other ancestors11 generations back: 16 other ancestors12 generations back: 15 other ancestors13 generations back: 3 other ancestors14 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K213504 · 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. · 1991−15−10−50
  1. Root · 18 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 14 generations between
  3. 3 generations backK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
  4. 2 generations backK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
  5. 1 generation backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
  6. This deviceK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
  7. Descendant · cites it directly · 2 of its ownK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
  8. Descendant · 2 generations on · 0 of its ownK253596 Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · 2026
  9. Descendant · 2 generations on · 0 of its ownK251645 Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B…Canon Medical Systems Corporation · 2025
Show all 18 generations
  1. Root · 18 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 17 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. 16 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
  4. 15 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
  5. 14 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
  6. 13 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
  7. 12 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
  8. 11 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
  9. 10 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
  10. 9 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
  11. 8 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
  12. 7 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
  13. 6 generations backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
  14. 5 generations backK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
  15. 4 generations backK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
  16. 3 generations backK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
  17. 2 generations backK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
  18. 1 generation backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
  19. This deviceK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024

Most influential descendants

Showing 3 of 3 · See all
  • K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024 · cites it directly2descendants
  • K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · 2026 · 2 generations on0descendants
  • K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−17K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
−16K020483Advantage Workstation 4.1GE Medical Systems20022
−15K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002—
−14K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20032
−13K040305VITREA2 Version 3.5Vital Images, Inc.2004—
−12K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041
−11K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20052
−10K061624Vitrea, Version 3.9Vital Images, Inc.20061
−9K071331Vitrea Version 4.0Vital Images, Inc.20071
−8K073156Qplaque MRMedis Medical Imaging Systems BV2008—
−7K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.2012—
−6K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation2017—
−5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation2018—
−4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation2018—
−3K192923Vitrea Software PackageCanon Medical Systems Corporation2020—
−2K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation2021—
−1K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software…Canon Medical Systems Corporation2022—
0 (this device)K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation2024—
+1K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation2024—
+2K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation2026—
+2K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B…Canon Medical Systems Corporation2025—

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202510
202610
FIG. 1 — Lineage of K232835, 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
*K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…
Summary page 5
…with 21 CFR System, X-ray, June 16, Medical Tomography K213504 Spectral Imaging §892.1750 Tomography, 2022…
Canon Medical Systems Corporation2022—

Also cleared against K213504: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242

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 12 months on median.
  • 59 of the 189 ancestors have a recall of any class.
  • Of its descendants, K242403 (Canon Medical Systems Corporation, 2024) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K213504.

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. 2024, 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 (277 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, 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 applications, in comparison to FBP and hybrid iterative reconstruction..

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K232835: Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232835

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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