510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Aquilion One

K113466510(k) TraditionalCleared Apr 10, 2012140-day reviewClass II21 CFR 892.1750Recalls 3

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

Toshiba Medical Systems Coporation, Japan · JAK System, X-Ray, Tomography, Computed

Cleared on Apr 10, 2012 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it. It has been recalled 3 times.

Decided
Apr 10, 2012
Review
140 days
Class
Class II
Product code
JAK
Recalls
3
Predicates
0

47 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 3 descendants cleared2014: 5 descendants cleared2015: 9 descendants cleared2017: 4 descendants cleared2016: 2 descendants cleared2018: 7 descendants cleared2020: 3 descendants cleared2025: 1 descendant cleared2019: 2 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2023: 2 descendants cleared2024: 3 descendants cleared2026: 1 descendant cleared2010201520202025
  1. This deviceK113466 Aquilion OneToshiba Medical Systems Coporation, Japan · 2012
  2. Descendant · cites it directly · 41 of its ownK122109 Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C · 2012 · Recalled
  3. Descendant · 2 generations on · 31 of its ownK132222 Aquilion One Vision, V6.0Toshibamedical Systems Corporation · 2013 · Recalled
  4. Descendant · 3 generations on · 23 of its ownK133497 Aquilion One VisionToshibamedical Systems Corporation · 2014
  5. Descendant · 3 generations on · 22 of its ownK142465 Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · Recalled
  6. Descendant · 4 generations on · 13 of its ownK151673 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · Recalled

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2012: 12013: 32014: 52015: 92016: 22017: 42018: 72019: 22020: 32021: 22022: 22023: 22024: 32025: 12026: 1
2012high 9 (2015) · low 1 (2012)2026

Most influential descendants

Showing 5 of 47 · See all
  • K122109Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C · 2012 · cites it directly41descendants
  • K132222Aquilion One Vision, V6.0Toshibamedical Systems Corporation · 2013 · 2 generations on31descendants
  • K133497Aquilion One VisionToshibamedical Systems Corporation · 2014 · 3 generations on23descendants
  • K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · 3 generations on22descendants
  • K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K113466Aquilion OneToshiba Medical Systems Coporation, Japan2012—
+1K122109Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C20121
+2K132222Aquilion One Vision, V6.0Toshibamedical Systems Corporation20132
+3K133497Aquilion One VisionToshibamedical Systems Corporation2014—
+3K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation20151
+4K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation20151

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201330
201450
201590
201620
201740
201870
201920
202030
202120
202220
202320
202430
202510
202610
FIG. 1 — Lineage of K113466, 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (47)

See all 47

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122109Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C201241
K123500Aquilion LB Triton V4.91Toshibamedical Systems Corporation20134

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 8, 2015Class IIZ-0014-2016Radiation Control for Health and Safety ActIf two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.
Nov 5, 2014Class IIZ-0472-2015Software designPotential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume…
Oct 1, 2013Class IIZ-1113-2014Software designToshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K122109 (Toshiba America Medical Systems, In.C, 2012) has gone furthest, with 41 descendants of its own.

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. 2012, 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—

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5 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K113466 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113466: Aquilion One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113466

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026