510(k) · Cleared
ClearedDigital Color Doppler Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shantou Institute of Ultrasonic Instuments · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 15, 2012 as substantially equivalent to K042326 (Ultrasonix Medical Corporation, 2004) after a 192-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it.
- Decided
- Jun 15, 2012
- Review
- 192 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K935595 (1995). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 3 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 2 generations backK020630 Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation · 2002
- 1 generation backK042326 Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation · 2004
- This deviceK113613 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments · 2012
- Descendant · cites it directly · 3 of its ownK173000 Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2017
- Descendant · 2 generations on · 0 of its ownK243178 Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243132 Digital Color Doppler Ultrasound Imaging System (Readius L15)…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK210317 Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2021
- Descendant · cites it directly · 0 of its ownK182165 Color Doppler Ultrasound System; Model: mEye1 and mEye2Shenzhen Well.D Medical Electronics Co., Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2017 · cites it directly3descendants
- K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2025 · 2 generations on0descendants
- K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd. · 2024 · 2 generations on0descendants
- K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2021 · 2 generations on0descendants
- K182165Color Doppler Ultrasound System; Model: mEye1 and mEye2Shenzhen Well.D Medical Electronics Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −3 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −2 | K020630 | Ultrasonix Ergosonix 500 Ultrasound Scanner | Ultrasonix Medical Corporation | 2002 | — |
| −1 | K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner | Ultrasonix Medical Corporation | 2004 | — |
| 0 (this device) | K113613 | Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | 2012 | — |
| +1 | K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300… | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2017 | — |
| +2 | K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color… | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025 | — |
| +2 | K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color… | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2024 | — |
| +2 | K210317 | Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W /… | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021 | — |
| +1 | K182165 | Color Doppler Ultrasound System; Model: mEye1 and mEye2 | Shenzhen Well.D Medical Electronics Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerSummary page 2…em 3. Predicate Device: The subject device is substantially equivalent to the device currently having FDA 510(k) clearance Ultrasonix Ergononix 500 Ultrasound Scanner (K042326) with respect to intended use, principles of operation and technological characteristics. 4. Device Description: The SlUT Apoge… | 2004 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K173000 (Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), 2017) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K042326.
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. 2012, 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, trans-vaginal and trans-rectal applications in B, M, PWD, CWD, Color Doppler and 3D imaging modes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113613: Digital Color Doppler Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113613
Report an extraction error
Are you the manufacturer?
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