510(k) · Cleared
ClearedOpus Diagnostic Ultrasound System & Transducers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chang Gung Medical Technology Co., Ltd. Linkou Fac · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 9, 2010 as substantially equivalent to K042369 (Sonoscape Company Limited, 2004) after a 64-day review. Its family tree reaches back 4 generations to 1994. 4 later devices descend from it.
- Decided
- Dec 9, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933202 (1994). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK933202 Venus Diagnostic Ultrasound SystemGE Medical Systems · 1994
- 3 generations backK970901 GE Logiq 500 Diagnostic Ultrasound SystemGE Medical Systems · 1997
- 2 generations backK991611 GE Logiq 500General Electric Co. · 1999
- 1 generation backK042369 Sonoscape Ultrasound System Ssi-1000/Ssi-5000Sonoscape Company Limited · 2004
- This deviceK102989 Opus Diagnostic Ultrasound System & TransducersChang Gung Medical Technology Co., Ltd. Linkou Fac · 2010
- Descendant · cites it directly · 3 of its ownK132690 UP600 Diagnostic Doppler Ultrasound SystemQisda Corporation · 2014
- Descendant · 2 generations on · 2 of its ownK172056 InnoSight Diagnostic Ultrasound SystemQisda Corporation · 2017
- Descendant · 3 generations on · 1 of its ownK181313 BenQ Diagnostic Ultrasound SystemQisda Corporation · 2018
- Descendant · 4 generations on · 0 of its ownK192254 InnoSight Diagnostic Ultrasound SystemQisda Corporation · 2019
Most influential descendants
Showing 4 of 4 · See all- K132690UP600 Diagnostic Doppler Ultrasound SystemQisda Corporation · 2014 · cites it directly3descendants
- K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation · 2017 · 2 generations on2descendants
- K181313BenQ Diagnostic Ultrasound SystemQisda Corporation · 2018 · 3 generations on1descendant
- K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933202 | Venus Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −3 | K970901 | GE Logiq 500 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| −2 | K991611 | GE Logiq 500 | General Electric Co. | 1999 | — |
| −1 | K042369 | Sonoscape Ultrasound System Ssi-1000/Ssi-5000 | Sonoscape Company Limited | 2004 | — |
| 0 (this device) | K102989 | Opus Diagnostic Ultrasound System & Transducers | Chang Gung Medical Technology Co., Ltd. Linkou Fac | 2010 | — |
| +1 | K132690 | UP600 Diagnostic Doppler Ultrasound System | Qisda Corporation | 2014 | — |
| +2 | K172056 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | 2017 | — |
| +3 | K181313 | BenQ Diagnostic Ultrasound System | Qisda Corporation | 2018 | — |
| +4 | K192254 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K042369 | Sonoscape Ultrasound System Ssi-1000/Ssi-5000Summary page 2…age 1 of 3 CGMC OPUS 5000 Diagnostic Ultrasound System Chang Gung Medical Technology Co., Ltd. The SonoScape Ultrasound System SSI1 000 ( K042369 ) is of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectivene… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132690 | UP600 Diagnostic Doppler Ultrasound System | 2014 | 3 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K132690 (Qisda Corporation, 2014) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K042369.
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?
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, tests, thyroid), heart soft tissue, Peripheral Vascular, Musculo-skeletal (conventional), Ob/Gyn and Urology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102989: Opus Diagnostic Ultrasound System & Transducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102989
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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