510(k) Report

510(k) · Cleared

Cleared

Aplio XG Diagnostic Ultrasound System

K103645510(k) SpecialCleared Jan 12, 201130-day reviewClass II21 CFR 892.1570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Toshiba Medical Systems Corporation, Japan · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Jan 12, 2011 after a 30-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 90 later devices descend from it.

Decided
Jan 12, 2011
Review
30 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
0

90 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2012: 2 descendants cleared2025: 9 descendants cleared2013: 3 descendants cleared2014: 8 descendants cleared2016: 5 descendants cleared2017: 8 descendants cleared2015: 2 descendants cleared2018: 11 descendants cleared2020: 7 descendants cleared2019: 5 descendants cleared2023: 7 descendants cleared2022: 5 descendants cleared2021: 4 descendants cleared2026: 7 descendants cleared2024: 6 descendants cleared2010201520202025
  1. This deviceK103645 Aplio XG Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan · 2011
  2. Descendant · cites it directly · 89 of its ownK110870 Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound…Toshiba America Medical Systems, In.C · 2011
  3. Descendant · 2 generations on · 85 of its ownK121422 Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan · 2012
  4. Descendant · 3 generations on · 82 of its ownK123992 Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013
  5. Descendant · 4 generations on · 72 of its ownK133761 Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014
  6. Descendant · 5 generations on · 49 of its ownK142517 SoftVueDelphinus Medical Technologies, Inc. · 2014

Showing 5 of 90 descendants. See all descendants

Descendants cleared per year

2011: 12012: 22013: 32014: 82015: 22016: 52017: 82018: 112019: 52020: 72021: 42022: 52023: 72024: 62025: 92026: 7
2011high 11 (2018) · low 1 (2011)2026

Most influential descendants

Showing 5 of 90 · See all
  • K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C · 2011 · cites it directly89descendants
  • K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan · 2012 · 2 generations on85descendants
  • K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation · 2013 · 3 generations on82descendants
  • K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation · 2014 · 4 generations on72descendants
  • K142517SoftVueDelphinus Medical Technologies, Inc. · 2014 · 5 generations on49descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K103645Aplio XG Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan2011—
+1K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio…Toshiba America Medical Systems, In.C2011—
+2K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan2012—
+3K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation2013—
+4K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation2014—
+5K142517SoftVueDelphinus Medical Technologies, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201220
201330
201480
201520
201650
201780
2018110
201950
202070
202140
202250
202370
202460
202590
202670
FIG. 1 — Lineage of K103645, 2011–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ITX? 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 ITX device

  1. #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (90)

See all 90

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

NumberDeviceApplicantDecidedDescendants
K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189

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, K110870 (Toshiba America Medical Systems, In.C, 2011) has gone furthest, with 89 descendants of its own.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · ITX

4in 2025

2007: 102008: 122009: 172010: 102011: 102012: 72013: 32014: 42015: 12016: 42017: 62018: 22019: 12020: 32021: 32022: 22023: 62024: 32025: 42026 (partial year): 6
2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007: 26 days median2008: 73 days median2009: 28 days median2010: 42 days median2011: 16 days median2012: 25 days median2013: 105 days median2014: 41 days median2016: 151 days median2017: 110 days median2020: 120 days median2021: 139 days median2023: 213 days median2024: 81 days median2025: 126 days median2026 (partial year): 158 days median
2007high 213 (2023) · low 16 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ITX

2in 2025

2008: 42009: 42010: 42011: 12012: 12014: 12015: 52017: 12018: 152020: 32021: 10, 10 Class I2022: 62023: 12024: 12025: 2
2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007: 162008: 392009: 232010: 302011: 342012: 292013: 382014: 432015: 1832016: 2692017: 4122018: 1302019: 1192020: 1162021: 1462022: 872023: 1382024: 9882025: 571
2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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
20071026016
20081273439
20091728423
20101042430
20111016134
2012725129
20133105038
2014441143
20151—5183
201641510269
201761101412
20182—15130
20191—0119
202031203116
2021313910 (10)146
20222—687
202362131138
20243811988
202541262571
202661580—

More from Toshiba Medical Systems Corporation…

9 FDA decisions under this applicant name. See the company

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  • K121911Octave Speeder SpineToshiba Medical Systems Corporation, Japan · 2012
  • K121910Octave Speeder HeadToshiba Medical Systems Corporation, Japan · 2012
  • K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan · 2012

Recent decisions in ITX

The ITX category page

  • K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
  • K261170BA-004CCFujifilm Corporation · 2026
  • K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
  • K260161SmartGuide Disposable Guides and GridsUC-CARE, Ltd. · 2026
  • K262474ND Needle Guidance SystemAccurate Access, LLC · 2026

https://510kreport.com/device/K103645 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103645: Aplio XG Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103645

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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