510(k) Report

510(k) · Cleared

Cleared

Aquilion One Vision

K133497510(k) TraditionalCleared Feb 10, 201488-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

Toshibamedical Systems Corporation · JAK System, X-Ray, Tomography, Computed

Cleared on Feb 10, 2014 as substantially equivalent to K132222 (Toshibamedical Systems Corporation, 2013) after an 88-day review. Its family tree reaches back 3 generations to 2012. 23 later devices descend from it.

Decided
Feb 10, 2014
Review
88 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K113466 (2012). 23 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 3 descendants cleared2016: 2 descendants cleared2018: 3 descendants cleared2017: 2 descendants cleared2019: 2 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 3 descendants cleared2025: 1 descendant cleared2026: 1 descendant clearedK113466 · Aquilion One · Toshiba Medical Systems Coporation, Japan · 2012 · recalledK122109 · Aquilion One Vision, V4.90 · Toshiba America Medical Systems, In.C · 2012 · recalledK132222 · Aquilion One Vision, V6.0 · Toshibamedical Systems Corporation · 2013 · recalled2010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 3 descendants8 generations forward: 2 descendants9 generations forward: 2 descendants K132222 · Aquilion One Vision, V6.0 · Toshibamedical Systems Corporation · 2013 · recalledK122109 · Aquilion One Vision, V4.90 · Toshiba America Medical Systems, In.C · 2012 · recalledK113466 · Aquilion One · Toshiba Medical Systems Coporation, Japan · 2012 · recalled0+5
  1. Root · 3 generations backK113466 Aquilion OneToshiba Medical Systems Coporation, Japan · 2012 · Recalled
  2. 2 generations backK122109 Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C · 2012 · Recalled
  3. 1 generation backK132222 Aquilion One Vision, V6.0Toshibamedical Systems Corporation · 2013 · Recalled
  4. This deviceK133497 Aquilion One VisionToshibamedical Systems Corporation · 2014
  5. Descendant · cites it directly · 22 of its ownK142465 Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · Recalled
  6. Descendant · 2 generations on · 13 of its ownK151673 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · Recalled
  7. Descendant · 2 generations on · 13 of its ownK151091 Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation · 2015
  8. Descendant · 3 generations on · 12 of its ownK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
  9. Descendant · 3 generations on · 12 of its ownK161009 Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4Toshibamedical Systems Corporation · 2016

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2015: 32016: 22017: 22018: 32019: 22020: 22021: 22022: 12023: 12024: 32025: 12026: 1
2015high 3 (2015) · low 1 (2022)2026

Most influential descendants

Showing 5 of 23 · See all
  • K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · cites it directly22descendants
  • K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · 2 generations on13descendants
  • K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation · 2015 · 2 generations on13descendants
  • K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017 · 3 generations on12descendants
  • K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4Toshibamedical Systems Corporation · 2016 · 3 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K113466Aquilion OneToshiba Medical Systems Coporation, Japan20123
−2K122109Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C20121
−1K132222Aquilion One Vision, V6.0Toshibamedical Systems Corporation20132
0 (this device)K133497Aquilion One VisionToshibamedical Systems Corporation2014—
+1K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation20151
+2K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation20151
+2K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation2015—
+3K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation2017—
+3K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4Toshibamedical Systems Corporation2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201530
201620
201720
201830
201920
202020
202120
202210
202310
202430
202510
202610
FIG. 1 — Lineage of K133497, 2012–2026Source: 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
*K132222Aquilion One Vision, V6.0
Summary page 1
…Product Marketed by 510(k) Number Clearance Date Aquilion ONE Vision, Toshiba America Medical K132222 November 7, 2013 TSX-301C/1 and 301C/2, Systems v6.00 12. REASON FO…
Toshibamedical Systems Corporation20132

Also cleared against K132222: 2 other devices →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation201522

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 2 years and passes through 3 companies; a new generation was cleared every 5 months on median.
  • 3 of the 3 ancestors have a recall of any class.
  • Of its descendants, K142465 (Toshibamedical Systems Corporation, 2015) has gone furthest, with 22 descendants of its own.
  • 2 other devices also cite its predicate K132222.

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. 2014, 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 whale 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.

Indications for use as stated in the FDA summary.

Also cleared against K132222

2 other devices cite the same predicate.

  • K142736XIDF-AWS801, Angio Workstation, v5.31Toshibamedical Systems Corporation · 2015
  • K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 20151 recall

More from Toshibamedical Systems Corporation

80 FDA decisions under this applicant name. See the company

  • K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation · 2018
  • K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 20181 recall
  • K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
  • K173382Vantage Galan 3T, V4.6Toshibamedical Systems Corporation · 2018
  • K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation · 2018

Recent decisions in JAK

The JAK category page

  • K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd. · 2026
  • K261225CAS-One IRCascination AG · 2026
  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K133497 · printed Nov 4, 2026

Cite this page

510(k) Report. “K133497: Aquilion One Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133497

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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