510(k) Report

510(k) · Cleared

Cleared

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

K161009510(k) TraditionalCleared Jul 22, 2016102-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 Jul 22, 2016 as substantially equivalent to K151673 (Toshibamedical Systems Corporation, 2015) after a 102-day review. Its family tree reaches back 6 generations to 2012. 12 later devices descend from it.

Decided
Jul 22, 2016
Review
102 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K113466 (2012). 12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2019: 2 descendants cleared2020: 1 descendant cleared2021: 1 descendant 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 · recalledK133497 · Aquilion One Vision · Toshibamedical Systems Corporation · 2014K142465 · Aquilion ONE Vision, v7.0 · Toshibamedical Systems Corporation · 2015 · recalledK151673 · Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) · Toshibamedical Systems Corporation · 2015 · recalled2010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 2 descendants8 generations forward: 2 descendants9 generations forward: 2 descendants K151673 · Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) · Toshibamedical Systems Corporation · 2015 · recalledK142465 · Aquilion ONE Vision, v7.0 · Toshibamedical Systems Corporation · 2015 · recalledK133497 · Aquilion One Vision · Toshibamedical Systems Corporation · 2014K132222 · 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 · recalled−50+5
  1. Root · 6 generations backK113466 Aquilion OneToshiba Medical Systems Coporation, Japan · 2012 · Recalled
  2. 5 generations backK122109 Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C · 2012 · Recalled
  3. 4 generations backK132222 Aquilion One Vision, V6.0Toshibamedical Systems Corporation · 2013 · Recalled
  4. 3 generations backK133497 Aquilion One VisionToshibamedical Systems Corporation · 2014
  5. 2 generations backK142465 Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation · 2015 · Recalled
  6. 1 generation backK151673 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation · 2015 · Recalled
  7. This deviceK161009 Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4Toshibamedical Systems Corporation · 2016
  8. Descendant · cites it directly · 11 of its ownK170177 Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation · 2017 · Recalled
  9. Descendant · 2 generations on · 10 of its ownK183046 Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation · 2019
  10. Descendant · 3 generations on · 9 of its ownK192188 Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation · 2019
  11. Descendant · 4 generations on · 8 of its ownK192828 Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation · 2020
  12. Descendant · 5 generations on · 7 of its ownK203225 Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation · 2021

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2017: 12019: 22020: 12021: 12022: 12023: 12024: 32025: 12026: 1
2017high 3 (2024) · low 0 (2018)2026

Most influential descendants

Showing 5 of 12 · See all
  • K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation · 2017 · cites it directly11descendants
  • K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation · 2019 · 2 generations on10descendants
  • K192188Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation · 2019 · 3 generations on9descendants
  • K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation · 2020 · 4 generations on8descendants
  • K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation · 2021 · 5 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K113466Aquilion OneToshiba Medical Systems Coporation, Japan20123
−5K122109Aquilion One Vision, V4.90Toshiba America Medical Systems, In.C20121
−4K132222Aquilion One Vision, V6.0Toshibamedical Systems Corporation20132
−3K133497Aquilion One VisionToshibamedical Systems Corporation2014—
−2K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation20151
−1K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)Toshibamedical Systems Corporation20151
0 (this device)K161009Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4Toshibamedical Systems Corporation2016—
+1K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation20171
+2K183046Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation2019—
+3K192188Aquilion ONE (TSX-306A/3) V10.0Canon Medical Systems Corporation2019—
+4K192828Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation2020—
+5K203225Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201920
202010
202110
202210
202310
202430
202510
202610
FIG. 1 — Lineage of K161009, 2012–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K151673Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
Summary page 5
…d America 21 CFR System, X‐ray, with FIRST Tomography K151673 11/27/2015 Medical 892.1750 Tomography, 1.0 (CCRS‐…
Toshibamedical Systems Corporation20151

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1Toshibamedical Systems Corporation201711

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 4 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • 5 of the 6 ancestors have a recall of any class.
  • Of its descendants, K170177 (Toshibamedical Systems Corporation, 2017) has gone furthest, with 11 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. 2016, 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.

FIRST 2.0 is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.

Indications for use as stated in the FDA summary.

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

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https://510kreport.com/device/K161009 · printed Nov 5, 2026

Cite this page

510(k) Report. “K161009: Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161009

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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