510(k) · Cleared
ClearedDigital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shantou Institute of Ultrasonic Instruments (Siui · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 15, 2011 as substantially equivalent to K102023 (Shantou Institute of Ultrasonic Instruments (Siui, 2010) after a 21-day review. Its family tree reaches back 1 generation to 2010. 6 later devices descend from it.
- Decided
- Apr 15, 2011
- Review
- 21 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102023 (2010). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK102023 Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500…Shantou Institute of Ultrasonic Instruments (Siui · 2010
- This deviceK110841 Digital Color Doppler Ultrasound Imaging System, Convex / Linear /…Shantou Institute of Ultrasonic Instruments (Siui · 2011
- Descendant · cites it directly · 5 of its ownK160853 Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2016
- Descendant · 2 generations on · 3 of its ownK173000 Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2017
- Descendant · 3 generations on · 0 of its ownK243178 Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK243132 Digital Color Doppler Ultrasound Imaging System (Readius L15)…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK210317 Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2016 · cites it directly5descendants
- K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2017 · 2 generations on3descendants
- K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2025 · 3 generations on0descendants
- K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2024 · 3 generations on0descendants
- K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102023 | Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex… | Shantou Institute of Ultrasonic Instruments (Siui | 2010 | — |
| 0 (this device) | K110841 | Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased… | Shantou Institute of Ultrasonic Instruments (Siui | 2011 | — |
| +1 | K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging… | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2016 | — |
| +2 | K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300… | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2017 | — |
| +3 | K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color… | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025 | — |
| +3 | K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color… | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2024 | — |
| +3 | K210317 | Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W /… | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 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 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102023 | Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex Array…Summary page 2…having FDA 510(k)' clearance SIUI Apogee 3500 Digital Color Doppler Ultrasound Imaging System, K102023 with respect to intended use, principles of operation and tec… | 2010 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System | 2016 | 5 |
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 no recall.
- Of its descendants, K160853 (Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110841: Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110841
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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