510(k) Report

510(k) · Cleared

Cleared

Xpress

K903701510(k) TraditionalCleared Nov 7, 199084-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 7, 1990 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.

Decided
Nov 7, 1990
Review
84 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 2 descendants cleared1999: 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 cleared1990200020102020
  1. This deviceK903701 XpressToshiba America Medical Systems, In.C · 1990
  2. Descendant · cites it directly · 19 of its ownK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · Recalled
  3. Descendant · 2 generations on · 15 of its ownK020385 CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002
  4. Descendant · 3 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 · 4 generations on · 12 of its ownK050458 TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · Recalled
  6. Descendant · 5 generations on · 4 of its ownK123500 Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1998: 21999: 22002: 22005: 22006: 12008: 12011: 12013: 12014: 22015: 22016: 12017: 12018: 22025: 1
1998high 2 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 21 · See all
  • K982265Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · cites it directly19descendants
  • K020385CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002 · 2 generations on15descendants
  • K022050CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion Advance Multi)Toshiba America Medical Systems, In.C · 2002 · 3 generations on14descendants
  • K050458TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · 4 generations on12descendants
  • K123500Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013 · 5 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903701XpressToshiba America Medical Systems, In.C1990—
+1K982265Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C19983
+2K020385CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C2002—
+3K022050CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion…Toshiba America Medical Systems, In.C2002—
+4K050458TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C20051
+5K123500Aquilion LB Triton V4.91Toshibamedical Systems Corporation2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200220
200520
200610
200810
201110
201310
201420
201520
201610
201710
201820
202510
FIG. 1 — Lineage of K903701, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K982265Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C199819
K982787Asteion CT Scanner, TSX-021AToshiba America Medical Systems, In.C19980

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, K982265 (Toshiba America Medical Systems, In.C, 1998) has gone furthest, with 19 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—

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146 FDA decisions under this applicant name. See the company

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The JAK category page

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https://510kreport.com/device/K903701 · printed Nov 4, 2026

Cite this page

510(k) Report. “K903701: Xpress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903701

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026