510(k) · Cleared
ClearedDigital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer, Convex Array Transducer, Phased Arr
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 Mar 5, 2010 as substantially equivalent to K042326 (Ultrasonix Medical Corporation, 2004) after a 164-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Mar 5, 2010
- Review
- 164 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. 1 later device descends from it, 1 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 deviceK092907 Digital Ultrasound Imaging System, Convex Array Transducer, Linear…Shantou Institute of Ultrasonic Instuments · 2010
- Descendant · cites it directly · 0 of its ownK103144 Digital Color Doppler Ultrasound Imagaing System; Convex / Linear…Shantou Institute of Ultrasonic Instruments (Siui · 2011
Most influential descendants
Showing 1 of 1 · See all- K103144Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array TransducerShantou Institute of Ultrasonic Instruments (Siui · 2011 · 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) | K092907 | Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array… | Shantou Institute of Ultrasonic Instuments | 2010 | — |
| +1 | K103144 | Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array… | Shantou Institute of Ultrasonic Instruments (Siui | 2011 | — |
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 |
|---|---|---|
| 2011 | 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…tem 3. Predicate Device: The subject device is substantially equivalent to the device currently having FDA 510(k) clearance Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326) with respect to intended use, principles of operation and technological characteristics. 4. Device Description: The SIUI CTS-8… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103144 | Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array Transducer | 2011 | 0 |
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 15 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, K103144 (Shantou Institute of Ultrasonic Instruments (Siui, 2011) has gone furthest, with 0 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. 2010, 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 ebdominal, pediatric, small argan, musculo-skeletal, cardi <, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092907: Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer, Convex Array Transducer, Phased Arr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092907
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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