510(k) Report

510(k) · Cleared

Recalled · 2011

Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7

K031469510(k) TraditionalCleared May 22, 200313-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 May 22, 2003 after a 13-day review. The FDA summary names its predicate without a number. 26 later devices descend from it. It has been recalled once.

Decided
May 22, 2003
Review
13 days
Class
Class II
Product code
JAK
Recalls
1
Predicates
0

26 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2005: 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 cleared200020052010201520202025
  1. This deviceK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003
  2. Descendant · cites it directly · 25 of its ownK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
  3. Descendant · 2 generations on · 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 · 3 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 · 4 generations on · 15 of its ownK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · Recalled
  6. Descendant · 5 generations on · 14 of its ownK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12008: 22011: 12012: 22013: 22015: 32016: 12017: 22018: 12019: 22020: 22022: 12023: 12024: 12025: 12026: 2
2003high 3 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 26 · See all
  • K033418TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · cites it directly25descendants
  • K051833TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT ScannerToshiba America Medical Systems, In.C · 2005 · 2 generations on24descendants
  • K080211Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · 3 generations on17descendants
  • K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · 4 generations on15descendants
  • K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013 · 5 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031469Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C2003—
+1K033418TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C20032
+2K051833TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT ScannerToshiba America Medical Systems, In.C2005—
+3K080211Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C20088
+4K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.20113
+5K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200820
201110
201220
201320
201530
201610
201720
201810
201920
202020
202210
202310
202410
202510
202620
FIG. 1 — Lineage of K031469, 2003–2026Source: 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
*—TSX-101A Aquilion CT with CGS-22A Multislice Kit
Named without a submission number
—

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K033418TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C200325

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 22, 2011Not classifiedZ-3198-2011Software designToshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-20IA: AQUlLlON LB; System, X-Ray…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033418 (Toshiba America Medical Systems, In.C, 2003) has gone furthest, with 25 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.

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The JAK category page

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https://510kreport.com/device/K031469 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031469: Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031469

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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