510(k) Report

510(k) · Cleared

Cleared

Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex Array Transducer, Model C3L60C

K102023510(k) TraditionalCleared Oct 19, 201092-day reviewClass II21 CFR 892.1550

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

Shantou Institute of Ultrasonic Instruments (Siui · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Oct 19, 2010 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Oct 19, 2010
Review
92 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

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

Descendants, by year cleared 2011: 1 descendant cleared2016: 1 descendant cleared2021: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2010201520202025
  1. This deviceK102023 Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500…Shantou Institute of Ultrasonic Instruments (Siui · 2010
  2. Descendant · cites it directly · 6 of its ownK110841 Digital Color Doppler Ultrasound Imaging System, Convex / Linear /…Shantou Institute of Ultrasonic Instruments (Siui · 2011
  3. Descendant · 2 generations on · 5 of its ownK160853 Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2016
  4. Descendant · 3 generations on · 3 of its ownK173000 Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2017
  5. Descendant · 4 generations on · 0 of its ownK243178 Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2025
  6. Descendant · 4 generations on · 0 of its ownK243132 Digital Color Doppler Ultrasound Imaging System (Readius L15)…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011: 12016: 12017: 12021: 22024: 12025: 1
2011high 2 (2021) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all
  • K110841Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array TransducerShantou Institute of Ultrasonic Instruments (Siui · 2011 · cites it directly6descendants
  • K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2016 · 2 generations on5descendants
  • K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2017 · 3 generations on3descendants
  • K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2025 · 4 generations on0descendants
  • K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K102023Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex…Shantou Institute of Ultrasonic Instruments (Siui2010—
+1K110841Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased…Shantou Institute of Ultrasonic Instruments (Siui2011—
+2K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2016—
+3K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2017—
+4K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd.2025—
+4K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201610
201710
202120
202410
202510
FIG. 1 — Lineage of K102023, 2010–2025Source: 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 IYN? 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 IYN device

  1. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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? (7)

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

NumberDeviceApplicantDecidedDescendants
K110841Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array TransducerShantou Institute of Ultrasonic Instruments (Siui20116

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, K110841 (Shantou Institute of Ultrasonic Instruments (Siui, 2011) has gone furthest, with 6 descendants of its own.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

More from Shantou Institute of Ultrasonic…

5 FDA decisions under this applicant name. See the company

  • K110841Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array TransducerShantou Institute of Ultrasonic Instruments (Siui · 2011
  • K103144Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array TransducerShantou Institute of Ultrasonic Instruments (Siui · 2011
  • K101008Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear ArrayShantou Institute of Ultrasonic Instruments (Siui · 2010
  • K061488CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging SystemShantou Institute of Ultrasonic Instruments (Siui · 2006

Recent decisions in IYN

The IYN category page

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  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K102023 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102023: Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex Array Transducer, Model C3L60C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102023

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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