510(k) Report

510(k) · Cleared

Recalled · 2007

Aquilion CT Scanner, Model TSX-101A

K982265510(k) TraditionalCleared Aug 26, 199858-day reviewClass II21 CFR 892.1750Recalls 3

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 Aug 26, 1998 as substantially equivalent to K903701 (Toshiba America Medical Systems, In.C, 1990) after a 58-day review. Its family tree reaches back 1 generation to 1990. 19 later devices descend from it. It has been recalled 3 times.

Decided
Aug 26, 1998
Review
58 days
Class
Class II
Product code
JAK
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K903701 (1990). 19 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2002: 2 descendants cleared2005: 2 descendants cleared2016: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2006: 1 descendant cleared2014: 2 descendants cleared2015: 2 descendants cleared2017: 1 descendant cleared2018: 2 descendants cleared2025: 1 descendant clearedK903701 · Xpress · Toshiba America Medical Systems, In.C · 19901990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K903701 · Xpress · Toshiba America Medical Systems, In.C · 19900+5
  1. Root · 1 generation backK903701 XpressToshiba America Medical Systems, In.C · 1990
  2. This deviceK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998
  3. Descendant · cites it directly · 15 of its ownK020385 CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002
  4. Descendant · 2 generations on · 14 of its ownK022050 CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A…Toshiba America Medical Systems, In.C · 2002
  5. Descendant · 3 generations on · 12 of its ownK050458 TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK123500 Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013
  7. Descendant · 4 generations on · 4 of its ownK111633 Aquilion LB Movement Base KitToshiba America Medical Systems, In.C · 2011

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1999: 22002: 22005: 22006: 12008: 12011: 12013: 12014: 22015: 22016: 12017: 12018: 22025: 1
1999high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 19 · See all
  • K020385CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002 · cites it directly15descendants
  • K022050CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion Advance Multi)Toshiba America Medical Systems, In.C · 2002 · 2 generations on14descendants
  • K050458TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · 3 generations on12descendants
  • K123500Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013 · 4 generations on4descendants
  • K111633Aquilion LB Movement Base KitToshiba America Medical Systems, In.C · 2011 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K903701XpressToshiba America Medical Systems, In.C1990—
0 (this device)K982265Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C1998—
+1K020385CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C2002—
+2K022050CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion…Toshiba America Medical Systems, In.C2002—
+3K050458TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C20051
+4K123500Aquilion LB Triton V4.91Toshibamedical Systems Corporation2013—
+4K111633Aquilion LB Movement Base KitToshiba America Medical Systems, In.C2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200220
200520
200610
200810
201110
201310
201420
201520
201610
201710
201820
202510
FIG. 1 — Lineage of K982265, 1990–2025Source: 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
*K903701Xpress
Summary page 1
…20563 Aquilion CT Scanner, TSX-101A Scanner, Computed Tomography, X-Ray [Fed. Reg. No. 892.1750, Pro. Code: 90JXD)] II (per 21 CFR 892.1750) Toshiba TSX-011A, Xpress [K903701/A] New Product Description of this Device: The Aquilion (TSX-101A) is a whole body CT Scanner that employs slip ring technolog…
Toshiba America Medical Systems, In.C1990—

Also cleared against K903701: 1 other device →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K020385CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C200215
K990134Multislice Upgrade Kit for Aquilion CT Scanner, TSX-101A (Aquilion,Multi)Toshiba America Medical Systems, In.C19992
K991766Ecg-Gating System for Aquilion CT Scanner, TSX-101AToshiba America Medical Systems, In.C19991

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 1, 2007Not classifiedZ-1708-2008Device DesignExcessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.
Oct 1, 2007Not classifiedZ-1707-2008Device DesignExcessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.
Mar 17, 2004Not classifiedZ-1031-04Software designErroneous patient data is entered. Previoius patient's demographics are recorded.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K020385 (Toshiba America Medical Systems, In.C, 2002) has gone furthest, with 15 descendants of its own.
  • 1 other device also cites its predicate K903701.

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K903701

1 other device cites the same predicate.

  • K982787Asteion CT Scanner, TSX-021AToshiba America Medical Systems, In.C · 19981 recall

More from Toshiba America Medical Systems, In.C

146 FDA decisions under this applicant name. See the company

  • K141472Vantage ElanToshiba America Medical Systems, In.C · 2014
  • K133553KalareToshiba America Medical Systems, In.C · 20143 recalls
  • K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C · 2014
  • 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/K982265 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982265: Aquilion CT Scanner, Model TSX-101A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982265

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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