510(k) Report

510(k) · Cleared

Cleared

TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner

K051833510(k) TraditionalCleared Jul 15, 20059-day reviewClass II21 CFR 892.1750

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 Jul 15, 2005 as substantially equivalent to K033418 (Toshiba America Medical Systems, In.C, 2003) after a 9-day review. Its family tree reaches back 2 generations to 2003. 24 later devices descend from it.

Decided
Jul 15, 2005
Review
9 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K031469 (2003). 24 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 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 clearedK031469 · Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 · Toshiba America Medical Systems, In.C · 2003 · recalledK033418 · TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners · Toshiba America Medical Systems, In.C · 2003 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant9 generations forward: 2 descendants10 generations forward: 2 descendants K033418 · TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners · Toshiba America Medical Systems, In.C · 2003 · recalledK031469 · Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7 · Toshiba America Medical Systems, In.C · 2003 · recalled0+5+10
  1. Root · 2 generations backK031469 Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C · 2003 · Recalled
  2. 1 generation backK033418 TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C · 2003 · Recalled
  3. This deviceK051833 TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT…Toshiba America Medical Systems, In.C · 2005
  4. Descendant · cites it directly · 17 of its ownK080211 Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · Recalled
  5. Descendant · 2 generations on · 15 of its ownK101888 Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · Recalled
  6. Descendant · 3 generations on · 14 of its ownK123509 Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013
  7. Descendant · 4 generations on · 11 of its ownK161748 SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
  8. Descendant · 5 generations on · 10 of its ownK163528 HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2008: 22011: 12012: 22013: 22015: 32016: 12017: 22018: 12019: 22020: 22022: 12023: 12024: 12025: 12026: 2
2008high 3 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 24 · See all
  • K080211Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C · 2008 · cites it directly17descendants
  • K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2011 · 2 generations on15descendants
  • K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc. · 2013 · 3 generations on14descendants
  • K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016 · 4 generations on11descendants
  • K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017 · 5 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K031469Aquilion Super 4 Multislice CT Scanner, Model TSX-101A/7Toshiba America Medical Systems, In.C20031
−1K033418TSX-101A/a and TSX-101A/C Aquilion Multislice CT ScannersToshiba America Medical Systems, In.C20032
0 (this device)K051833TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT ScannerToshiba America Medical Systems, In.C2005—
+1K080211Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C20088
+2K101888Scenaria Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.20113
+3K123509Scenaria Phase 2 Whole-Body X-Ray CT SystemHitachi Medical Systems America, Inc.2013—
+4K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.2016—
+5K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201110
201220
201320
201530
201610
201720
201810
201920
202020
202210
202310
202410
202510
202620
FIG. 1 — Lineage of K051833, 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
*K033418TSX-101A/a and TSX-101A/C Aquilion Multislice CT Scanners
Summary page 1
…J, Federal Diagnostic X-ray Equipment Standard Predicate Device(s): TSX-101A/A, /C,Aquilion MS-64/Aquilion MS-32 [k033418] Reason For Submission New device Description of this Device:…
Toshiba America Medical Systems, In.C20032

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K080211Model TSX-101A/H/I Aquilion 32/64 SP CT SystemToshiba America Medical Systems, In.C200817
K130960Suresubtraction OrthoToshibamedical Systems Corporation20133
K083282Model TSX-301B Aquilion CT SystemToshiba America Medical Systems, In.C20081

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K080211 (Toshiba America Medical Systems, In.C, 2008) has gone furthest, with 17 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

  • 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

  • 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/K051833 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051833: TSX-101A/H Aquilion 64 SP CT Scanner; TSX-101A/I Aquilion 32 SP CT Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051833

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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