510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Aquilion RXL

K121553510(k) TraditionalCleared Jul 26, 201262-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 Jul 26, 2012 as substantially equivalent to K093891 (Toshibamedical Systems Corporation, 2010) after a 62-day review. Its family tree reaches back 1 generation to 2010. 13 later devices descend from it. It has been recalled once.

Decided
Jul 26, 2012
Review
62 days
Class
Class II
Product code
JAK
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K093891 (2010). 13 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2019: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2021: 2 descendants cleared2020: 2 descendants cleared2023: 3 descendants cleared2026: 1 descendant clearedK093891 · Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 · Toshibamedical Systems Corporation · 2010 · recalled2010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K093891 · Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 · Toshibamedical Systems Corporation · 2010 · recalled0+5
  1. Root · 1 generation backK093891 Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation · 2010 · Recalled
  2. This deviceK121553 Aquilion RXLToshibamedical Systems Corporation · 2012
  3. Descendant · cites it directly · 11 of its ownK151833 Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016
  5. Descendant · 3 generations on · 9 of its ownK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021
  7. Descendant · 5 generations on · 3 of its ownK222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 22019: 12020: 22021: 22023: 32026: 1
2015high 3 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 13 · See all
  • K151833Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015 · cites it directly11descendants
  • K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016 · 2 generations on10descendants
  • K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · 3 generations on9descendants
  • K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021 · 4 generations on4descendants
  • K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K093891Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation20101
0 (this device)K121553Aquilion RXLToshibamedical Systems Corporation2012—
+1K151833Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation20151
+2K153263Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation2016—
+3K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation20171
+4K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation2021—
+5K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201720
201910
202020
202120
202330
202610
FIG. 1 — Lineage of K121553, 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? (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
*K093891Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2
Summary page 1
…JAK - System, Computed Tomography 9. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard 10. PREDICATE DEVICE: TSX-301A12 - K093891 11. REASON FOR SUBMISSION: Modification of a cleared device 12. DEVICE DESCRIPTION: The TSX-1O1A/R is a whole body CT s…
Toshibamedical Systems Corporation20101

Also cleared against K093891: 1 other device →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K151833Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation201511
K190505Low Dose Lung Screening OptionCanon Medical Systems Corporation20190

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

Recalls of this device

DateClassRecallRoot causeReason
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?

  • Its one ancestor has a recall.
  • Of its descendants, K151833 (Toshibamedical Systems Corporation, 2015) has gone furthest, with 11 descendants of its own.
  • 1 other device also cites its predicate K093891.

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 a acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion RXL 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.

Also cleared against K093891

1 other device cites the same predicate.

  • K110066Aquilion PrimeToshiba America Medical Systems, In.C · 2012

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/K121553 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121553: Aquilion RXL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121553

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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