510(k) Report

510(k) · Cleared

Recalled · 2009

TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners

K033418510(k) TraditionalCleared Nov 10, 200314-day reviewClass II21 CFR 892.1750Recalls 2

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 Nov 10, 2003 as substantially equivalent to K031469 (Toshiba America Medical Systems, In.C, 2003) after a 14-day review. Its family tree reaches back 1 generation to 2003. 25 later devices descend from it. It has been recalled 2 times.

Decided
Nov 10, 2003
Review
14 days
Class
Class II
Product code
JAK
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K031469 (2003). 25 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2008: 2 descendants cleared2013: 2 descendants cleared2012: 2 descendants cleared2011: 1 descendant cleared2015: 3 descendants cleared2018: 1 descendant cleared2016: 1 descendant cleared2020: 2 descendants cleared2019: 2 descendants cleared2017: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants clearedReference device: K022050 · CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion Advance Multi) · Toshiba America Medical Systems, In.C · 2002K031469 · Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 · Toshiba America Medical Systems, In.C · 2003 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant10 generations forward: 2 descendants11 generations forward: 2 descendants K031469 · Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 · Toshiba America Medical Systems, In.C · 2003 · recalled0+5+10
  1. Root · 1 generation backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
  2. This deviceK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003
  3. Descendant · cites it directly · 24 of its ownK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
  4. Descendant · 2 generations on · 17 of its ownK080211 Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
  5. Descendant · 3 generations on · 15 of its ownK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · Recalled
  6. Descendant · 4 generations on · 14 of its ownK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013
  7. Descendant · 5 generations on · 11 of its ownK161748 SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2005: 12008: 22011: 12012: 22013: 22015: 32016: 12017: 22018: 12019: 22020: 22022: 12023: 12024: 12025: 12026: 2
2005high 3 (2015) · low 0 (2006)2026

Most influential descendants

Showing 5 of 25 · See all
  • K051833TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT ScannerToshiba America Medical Systems, In.C · 2005 · cites it directly24descendants
  • K080211Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · 2 generations on17descendants
  • K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · 3 generations on15descendants
  • K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013 · 4 generations on14descendants
  • K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016 · 5 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K031469Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C20031
0 (this device)K033418TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C2003—
+1K051833TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT ScannerToshiba America Medical Systems, In.C2005—
+2K080211Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C20088
+3K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.20113
+4K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.2013—
+5K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200820
201110
201220
201320
201530
201610
201720
201810
201920
202020
202210
202310
202410
202510
202620
FIG. 1 — Lineage of K033418, 2003–2026Source: 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? (3)

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
*K031469Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7
Summary page 1
…ated accessories. Materials and construction are similar to the Aquilion CT Scanner Multi-slice 16 (CGS31A) [KO220501 and the TSX- l O l N 7 Aquilion Super 4 CT Scanner [K031469], and are compliant with IEC60601-1 and associated collateral and particular standards, and applicable sections of 21 CFR Subchap…
Toshiba America Medical Systems, In.C20031
*—TSX-101N8 Aquilion 16 CT
Named without a submission number
—
*—TSXC-101A/8 CT System
Named without a submission number
—
†K022050CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion Advance Multi)Toshiba America Medical Systems, In.C2002—

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K051833TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT ScannerToshiba America Medical Systems, In.C200524

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 8, 2009Not classifiedZ-1164-2010Component design/selectionToshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large…
Jan 8, 2009Not classifiedZ-1165-2010Component design/selectionToshiba America Medical Systems Inc (TAMS) has initiated a field correction on the Aquilion 32 CT Scanners due to the potential for the bolus tracking software (SureStart) to cause delay of the helical scan, up to 10 seconds, when large…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K051833 (Toshiba America Medical Systems, In.C, 2005) has gone furthest, with 24 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.

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?

X-ray imaging of whole body - Computerized Tomography

Including:

Axial

Volumetric (Helical)

CT Fluoroscopy

Indications for use as stated in the FDA summary.

More from Toshiba America Medical Systems, In.C

146 FDA decisions under this applicant name. See the company

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  • 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

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https://510kreport.com/device/K033418 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033418: TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033418

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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