510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Aquilion Lightning, TSX-036A/1, V8.4

K170019510(k) TraditionalCleared Feb 2, 201730-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

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

Cleared on Feb 2, 2017 as substantially equivalent to K153263 (Toshibamedical Systems Corporation, 2016) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 2010. 9 later devices descend from it. It has been recalled once.

Decided
Feb 2, 2017
Review
30 days
Class
Class II
Product code
JAK
Recalls
1
Predicates
2

Its longest line of descent runs back 4 generations to K093891 (2010). 7 ancestors in all. 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2013: 1 other ancestor2012: 1 other ancestor2021: 2 descendants cleared2017: 1 descendant cleared2020: 2 descendants cleared2023: 3 descendants cleared2026: 1 descendant clearedReference device: K023760 · CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B · Toshiba America Medical Systems, In.C · 2002Reference device: K043111 · Plaqueview Software, Model CSPV-0001A · Toshiba America Medical Systems, In.C · 2004Reference device: K991766 · Ecg-Gating System for Aquilion CT Scanner, TSX-101A · Toshiba America Medical Systems, In.C · 1999Reference device: K142465 · Aquilion ONE Vision, v7.0 · Toshibamedical Systems Corporation · 2015 · recalledReference device: K143294 · Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways · Toshibamedical Systems Corporation · 2015Reference device: K090504 · CSBP-001A Body Perfusion System · Toshibamedical Systems Corporation · 2009K093891 · Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 · Toshibamedical Systems Corporation · 2010 · recalledK121553 · Aquilion RXL · Toshibamedical Systems Corporation · 2012 · recalledK151833 · Aquilion Lightning (TSX-035A/2, V7.0) · Toshibamedical Systems Corporation · 2015 · recalledK153263 · Aquilion Lightning, TSX-035A/4 and /5, V7.0 · Toshibamedical Systems Corporation · 20162010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K153263 · Aquilion Lightning, TSX-035A/4 and /5, V7.0 · Toshibamedical Systems Corporation · 2016K151833 · Aquilion Lightning (TSX-035A/2, V7.0) · Toshibamedical Systems Corporation · 2015 · recalledK121553 · Aquilion RXL · Toshibamedical Systems Corporation · 2012 · recalledK093891 · Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 · Toshibamedical Systems Corporation · 2010 · recalled0+5
  1. Root · 4 generations backK093891 Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation · 2010 · Recalled
  2. 3 generations backK121553 Aquilion RXLToshibamedical Systems Corporation · 2012 · Recalled
  3. 2 generations backK151833 Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015 · Recalled
  4. 1 generation backK153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016
  5. This deviceK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017
  6. Descendant · cites it directly · 4 of its ownK201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021
  7. Descendant · 2 generations on · 3 of its ownK222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023
  8. Descendant · cites it directly · 3 of its ownK172188 Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation · 2017 · Recalled
  9. Descendant · 3 generations on · 2 of its ownK231281 Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation · 2023
  10. Descendant · 2 generations on · 2 of its ownK192832 Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation · 2020 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2017: 12020: 22021: 22023: 32026: 1
2017high 3 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 9 · See all
  • K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021 · cites it directly4descendants
  • K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023 · 2 generations on3descendants
  • K172188Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation · 2017 · cites it directly3descendants
  • K231281Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation · 2023 · 3 generations on2descendants
  • K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation · 2020 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K093891Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation20101
−3K121553Aquilion RXLToshibamedical Systems Corporation20121
−2K151833Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation20151
−1K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation2016—
0 (this device)K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation2017—
+1K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation2021—
+2K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation2023—
+1K172188Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation20171
+3K231281Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation2023—
+2K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation20201

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202020
202120
202330
202610
FIG. 1 — Lineage of K170019, 2010–2026Source: 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? (2)

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
*K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0
Summary page 5
…The Aquilion Lightning, TSX‐036A/1, v8.4, is substantially equivalent to the Aquilion Lightning, TSX‐ 035A/4 and /5, v7.0, which received premarket clearance under K153263 and the Aquilion PRIME, TSX‐303A, V6.0, which received premarket clearance under K141741, both of which are marketed by T…
Toshibamedical Systems Corporation2016—
*K141741Aquilion Prime, V6.00
Summary page 5
…Computed PRIME TSX‐ America 21 CFR System, X‐ray, Tomography K141741 November 26, 2014 303A/F, Medical 892.1750 Tomography,…
Toshibamedical Systems Corporation20142
†K023760CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001BToshiba America Medical Systems, In.C2002—
†K043111Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C2004—
†K991766Ecg-Gating System for Aquilion CT Scanner, TSX-101AToshiba America Medical Systems, In.C1999—
†K142465Aquilion ONE Vision, v7.0Toshibamedical Systems Corporation20151
†K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation2015—
†K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation2009—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation20214
K172188Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation20173

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 25, 2019Class IIZ-1719-2020Software designScanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
  • 5 of the 7 ancestors have a recall of any class.
  • Of its descendants, K201836 (Canon Medical Systems Corporation, 2021) has gone furthest, with 4 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. 2017, 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.

The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

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

  • 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/K170019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170019: Aquilion Lightning, TSX-036A/1, V8.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170019

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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