510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Aquilion One Vision, V4.90

K122109510(k) TraditionalCleared Sep 21, 201266-day reviewClass II21 CFR 892.1750Recalls 1

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

Toshiba America Medical Systems, In.C · JAK System, X-Ray, Tomography, Computed

Cleared on Sep 21, 2012 as substantially equivalent to K113466 (Toshiba Medical Systems Coporation, Japan, 2012) after a 66-day review. Its family tree reaches back 1 generation to 2012. 41 later devices descend from it. It has been recalled once.

Decided
Sep 21, 2012
Review
66 days
Class
Class II
Product code
JAK
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K113466 (2012). 41 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2014: 4 descendants cleared2013: 2 descendants cleared2015: 8 descendants cleared2016: 2 descendants cleared2018: 6 descendants cleared2017: 3 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 clearedK113466 · Aquilion One · Toshiba Medical Systems Coporation, Japan · 2012 · recalled2010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 9 descendants5 generations forward: 3 descendants6 generations forward: 3 descendants7 generations forward: 3 descendants8 generations forward: 4 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K113466 · Aquilion One · Toshiba Medical Systems Coporation, Japan · 2012 · recalled0+5+10
  1. Root · 1 generation backK113466 Aquilion OneToshiba Medical Systems Coporation, Japan · 2012 · Recalled
  2. This deviceK122109 Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C · 2012
  3. Descendant · cites it directly · 31 of its ownK132222 Aquilion One Vision, V6.0Toshibamedical Systems Corporation · 2013 · Recalled
  4. Descendant · 2 generations on · 23 of its ownK133497 Aquilion One VisionToshibamedical Systems Corporation · 2014
  5. Descendant · 2 generations on · 22 of its ownK142465 Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · Recalled
  6. Descendant · 3 generations on · 13 of its ownK151673 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · Recalled
  7. Descendant · 3 generations on · 13 of its ownK151091 Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation · 2015

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2013: 22014: 42015: 82016: 22017: 32018: 62019: 22020: 32021: 22022: 22023: 22024: 32025: 12026: 1
2013high 8 (2015) · low 1 (2025)2026

Most influential descendants

Showing 5 of 41 · See all
  • K132222Aquilion One Vision, V6.0Toshibamedical Systems Corporation · 2013 · cites it directly31descendants
  • K133497Aquilion One VisionToshibamedical Systems Corporation · 2014 · 2 generations on23descendants
  • K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · 2 generations on22descendants
  • K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · 3 generations on13descendants
  • K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation · 2015 · 3 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K113466Aquilion OneToshiba Medical Systems Coporation, Japan20123
0 (this device)K122109Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C2012—
+1K132222Aquilion One Vision, V6.0Toshibamedical Systems Corporation20132
+2K133497Aquilion One VisionToshibamedical Systems Corporation2014—
+2K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation20151
+3K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation20151
+3K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201440
201580
201620
201730
201860
201920
202030
202120
202220
202320
202430
202510
202610
FIG. 1 — Lineage of K122109, 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
*K113466Aquilion One
Summary page 1
…hy 10. PERFORMANCE STANDARD: 21 CFR Subichapter J, Federal Diagnostic X-ray Equipment Standard 11. PREDICATE DEVICE: Aquilion ONE TSX-301A12, w/4.74ER K1 13466 Toshiba America Medical Systems, Inc. 12. REASON FOR SUBMISSION: Modification of a cleared device…
Toshiba Medical Systems Coporation, Japan20123

Also cleared against K113466: 1 other device →

What descends from it? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K132222Aquilion One Vision, V6.0Toshibamedical Systems Corporation201331
K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation20143
K130960Suresubtraction OrthoToshibamedical Systems Corporation20133
K142697NExCT 7Neurologica Corporation20140
K133324Suresubtraction LungToshiba Medical Systems Corporation, Japan20140

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 14, 2012Class IIZ-1068-2013Process designDue to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K132222 (Toshibamedical Systems Corporation, 2013) has gone furthest, with 31 descendants of its own.
  • 1 other device also cites its predicate K113466.

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—

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 and qualified physician.

Indications for use as stated in the FDA summary.

Also cleared against K113466

1 other device cites the same predicate.

  • K123500Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013

More from Toshiba America Medical Systems, In.C

146 FDA decisions under this applicant name. See the company

  • K141472Vantage ElanToshiba America Medical Systems, In.C · 2014
  • K133553KalareToshiba America Medical Systems, In.C · 20143 recalls
  • K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C · 2014
  • K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
  • K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C · 2013

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/K122109 · printed Nov 4, 2026

Cite this page

510(k) Report. “K122109: Aquilion One Vision, V4.90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122109

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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