510(k) Report

510(k) · Cleared

Cleared

TSX-301A, Aquilion One CT System

K063189510(k) TraditionalCleared Nov 3, 200614-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 Nov 3, 2006 after a 14-day review. The FDA summary names its predicate without a number. 67 later devices descend from it.

Decided
Nov 3, 2006
Review
14 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
0

67 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 3 descendants cleared2015: 8 descendants cleared2013: 1 descendant cleared2011: 3 descendants cleared2012: 2 descendants cleared2018: 6 descendants cleared2014: 3 descendants cleared2016: 7 descendants cleared2017: 5 descendants cleared2020: 4 descendants cleared2019: 4 descendants cleared2021: 3 descendants cleared2023: 4 descendants cleared2022: 2 descendants cleared2024: 3 descendants cleared2025: 6 descendants cleared2026: 2 descendants cleared20052010201520202025
  1. This deviceK063189 TSX-301A, Aquilion One CT SystemToshiba America Medical Systems, In.C · 2006
  2. Descendant · cites it directly · 63 of its ownK081022 Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · Recalled
  3. Descendant · 2 generations on · 53 of its ownK103127 Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · Recalled
  4. Descendant · 3 generations on · 49 of its ownK130901 Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
  5. Descendant · 2 generations on · 36 of its ownK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
  6. Descendant · 4 generations on · 35 of its ownK143401 SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · Recalled

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2007: 12008: 32011: 32012: 22013: 12014: 32015: 82016: 72017: 52018: 62019: 42020: 42021: 32022: 22023: 42024: 32025: 62026: 2
2007high 8 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 67 · See all
  • K081022Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · cites it directly63descendants
  • K103127Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · 2 generations on53descendants
  • K130901Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014 · 3 generations on49descendants
  • K082220Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on36descendants
  • K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · 4 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K063189TSX-301A, Aquilion One CT SystemToshiba America Medical Systems, In.C2006—
+1K081022Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc.20083
+2K103127Somatom Definition asSiemens Medical Solutions USA, Inc.20116
+3K130901Somatom Definition as OpenSiemens Medical Systems, Inc.2014—
+2K082220Somatom Flash DSSiemens Medical Solutions USA, Inc.2008—
+4K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc.20153

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200830
201130
201220
201310
201430
201580
201670
201750
201860
201940
202040
202130
202220
202340
202430
202560
202620
FIG. 1 — Lineage of K063189, 2006–2026Source: 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
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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-IO1A/I Aquilion 64 SP CT System
Named without a submission number
—

What descends from it? (67)

See all 67

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

NumberDeviceApplicantDecidedDescendants
K081022Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc.200863
K072606Aquilion One TSX-301A/2 Computed Tomography SystemToshiba America Medical Systems, In.C20072

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?

  • Of its descendants, K081022 (Siemens Medical Solutions USA, Inc., 2008) has gone furthest, with 63 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?

Acquisition and display of axial x-ray images of the whole body to include the head.

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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  • 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/K063189 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063189: TSX-301A, Aquilion One CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063189

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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