510(k) Report

510(k) · Cleared

Cleared

Aquilion Prime, V5.00

K130645510(k) TraditionalCleared Jun 6, 201387-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

Toshibamedical Systems Corporation · JAK System, X-Ray, Tomography, Computed

Cleared on Jun 6, 2013 as substantially equivalent to K120710 (Toshibamedical Systems Corporation, 2012) after an 87-day review. Its family tree reaches back 1 generation to 2012. 19 later devices descend from it.

Decided
Jun 6, 2013
Review
87 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K120710 (2012). 19 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2017: 2 descendants cleared2015: 1 descendant cleared2018: 2 descendants cleared2021: 2 descendants cleared2020: 2 descendants cleared2019: 1 descendant cleared2025: 2 descendants cleared2022: 1 descendant cleared2023: 4 descendants cleared2026: 1 descendant clearedK120710 · Aquilion Prime · Toshibamedical Systems Corporation · 2012 · recalled2010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K120710 · Aquilion Prime · Toshibamedical Systems Corporation · 2012 · recalled0+5
  1. Root · 1 generation backK120710 Aquilion PrimeToshibamedical Systems Corporation · 2012 · Recalled
  2. This deviceK130645 Aquilion Prime, V5.00Toshibamedical Systems Corporation · 2013
  3. Descendant · cites it directly · 18 of its ownK141741 Aquilion Prime, V6.00Toshibamedical Systems Corporation · 2014 · Recalled
  4. Descendant · 2 generations on · 9 of its ownK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · Recalled
  5. Descendant · 3 generations on · 4 of its ownK201836 Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021
  6. Descendant · 2 generations on · 4 of its ownK173468 Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 2018 · Recalled
  7. Descendant · 4 generations on · 3 of its ownK222819 Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 22018: 22019: 12020: 22021: 22022: 12023: 42025: 22026: 1
2014high 4 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 19 · See all
  • K141741Aquilion Prime, V6.00Toshibamedical Systems Corporation · 2014 · cites it directly18descendants
  • K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · 2 generations on9descendants
  • K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · 2021 · 3 generations on4descendants
  • K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 2018 · 2 generations on4descendants
  • K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation · 2023 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K120710Aquilion PrimeToshibamedical Systems Corporation20122
0 (this device)K130645Aquilion Prime, V5.00Toshibamedical Systems Corporation2013—
+1K141741Aquilion Prime, V6.00Toshibamedical Systems Corporation20142
+2K170019Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation20171
+3K201836Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation2021—
+2K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation20181
+4K222819Aquilion Serve (TSX-307A/1) V1.2 with AiCE-iCanon Medical Systems Corporation2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201720
201820
201910
202020
202120
202210
202340
202520
202610
FIG. 1 — Lineage of K130645, 2012–2026Source: 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? (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
*K120710Aquilion Prime
Summary page 1
…Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] 11. PREDICATE DEVICE: Product Marketed by 510{k) Number Clearance Date TSX-302A/2, Aquition Toshiba America K120710 April 6, 2012 Prime CT System -Medical Systems Page 10f 3 March 2013 510(K): Aquilion PRIME, TSX-303A/2 and 303A/6, V5.00 Page 1…
Toshibamedical Systems Corporation20122

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K141741Aquilion Prime, V6.00Toshibamedical Systems Corporation201418

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?

  • Its one ancestor has a recall.
  • Of its descendants, K141741 (Toshibamedical Systems Corporation, 2014) has gone furthest, with 18 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. 2013, this device’s year, is highlighted.

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?

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

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

More from Toshibamedical Systems Corporation

80 FDA decisions under this applicant name. See the company

  • K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation · 2018
  • K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 20181 recall
  • K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
  • K173382Vantage Galan 3T, V4.6Toshibamedical Systems Corporation · 2018
  • K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation · 2018

Recent decisions in JAK

The JAK category page

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https://510kreport.com/device/K130645 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130645: Aquilion Prime, V5.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130645

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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