510(k) · Cleared
ClearedOPUSWAVE Dual Sensor Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Thi Plant · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Jul 2, 2025 as substantially equivalent to K152316 (Boston Scientific, 2015) and 1 other predicate after a 118-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jul 2, 2025
- Review
- 118 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921750 (1992). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- 6 generations backK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
- 5 generations backK051679 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2005 · Recalled
- 4 generations backK072517 Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp · 2007 · Recalled
- 3 generations backK123535 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- 2 generations backK130243 Ilab Ultrasound Imaging SystemBoston Scientific Corp · 2013
- 1 generation backK152316 iLab Ultrasound Imaging SystemBoston Scientific · 2015
- This deviceK250684 OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921750 | Cvis Insight Iii System | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| −6 | K980851 | Galaxy Intravascular Ultrasound System, Model I5028 | Boston Scientific Corp | 1998 | — |
| −5 | K051679 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2005 | 2 |
| −4 | K072517 | Ilab Ultrasound Imaging System, Version 1.3 | Boston Scientific Corp | 2007 | 1 |
| −3 | K123535 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| −2 | K130243 | Ilab Ultrasound Imaging System | Boston Scientific Corp | 2013 | — |
| −1 | K152316 | iLab Ultrasound Imaging System | Boston Scientific | 2015 | — |
| 0 (this device) | K250684 | OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 NQQ? 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 NQQ device
- #1 K251730 LIA Console (542-7)score 16.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K152316 | iLab Ultrasound Imaging SystemSummary page 5…FR 892.1560 Product Code(s): NQQ / IYO III. Predicate Device Predicate Device#1, iLab Ultrasound Imaging System cleared under K152316. Predicate Device#2, Ilumien Optis cleared under K141453. IV. Device Description The OPUSWAVE Dual Sensor Imagi… | 2015 |
| * | K141453 | Ilumien Optis, Dragonfly Optis Imaging CatheterSummary page 5…Q / IYO III. Predicate Device Predicate Device#1, iLab Ultrasound Imaging System cleared under K152316. Predicate Device#2, Ilumien Optis cleared under K141453. IV. Device Description The OPUSWAVE Dual Sensor Imaging System consists of a wheeled console with monitor, key… | 2014 |
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 33 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All NQQ devicesNQQ System, Imaging, Optical Coherence Tomography (Oct): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NQQ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQQ
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQQ
2in 2025
MAUDE reports naming product code NQQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 82 | 1 | 0 |
| 2011 | 2 | — | 1 | 2 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 5 | 91 | 0 | 3 |
| 2016 | 5 | 91 | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 84 | 0 | 6 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 3 | 86 | 0 | 6 |
| 2024 | 2 | — | 0 | 6 |
| 2025 | 8 | 146 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OPUSWAVE System with DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures
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/K250684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250684: OPUSWAVE Dual Sensor 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/K250684
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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