510(k) · Cleared
ClearedOPUS 5100 Diagnostic Doppler Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chang Gung Medical Technology Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 3, 2015 as substantially equivalent to K131088 (Sonoscape Company Limited, 2013) after a 323-day review. Its family tree reaches back 2 generations to 2011.
- Decided
- Sep 3, 2015
- Review
- 323 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K112602 (2011). No later device cites it as a predicate yet.
- Root · 2 generations backK112602 S6 Diagnostic Ultrasound SystemSonoscape Company Limited · 2011
- 1 generation backK131088 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited · 2013
- This deviceK142982 OPUS 5100 Diagnostic Doppler Ultrasound SystemChang Gung Medical Technology Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K112602 | S6 Diagnostic Ultrasound System | Sonoscape Company Limited | 2011 | — |
| −1 | K131088 | Portable Digital Color Doppler Ultrasound System | Sonoscape Company Limited | 2013 | — |
| 0 (this device) | K142982 | OPUS 5100 Diagnostic Doppler Ultrasound System | Chang Gung Medical Technology Co., Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K131088 | Portable Digital Color Doppler Ultrasound SystemSummary page 27…cation of the Predicate Device Predicate Device Name: Portable Digital Color Doppler Ultrasound System Model: S9 Manufacturer: SonoScape Company Limited 510(k) Number: K131088 510(k) Summary Page 1 of 6 \ Cy 0= Chang Gung Medical Technology Co., Ltd. OPUS 5100 Diagnostic Doppler Ultraso… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K131088.
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. 2015, 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?
OPUS 5100 Diagnostic Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument
intended for use by a qualified physician for evaluation of Fetal, Abdomen; Pediatric; Small Organ(breast,
thyroid, tests); Cephalic (adult and neonatal); Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional
and Superficial); Ob/GYN; Urology; Cardiac (adult and pediatric) and Peripheral Vascular.
The following transducers are intended for use with OPUS 5100 Diagnostic Doppler Ultrasound
System.
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/K142982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142982: OPUS 5100 Diagnostic Doppler Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142982
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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