Class Class II
OPUSWAVE Dual Sensor Imaging System (K250684)
Description
OPUSWAVE Dual Sensor Imaging System by Terumo Cardiovascular Systems Thi Plant, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250684
Clearance Date2025-07-02
Clearance TypeTraditional
Product CodeNQQ
Regulation Number892.1560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250684
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. OPUSWAVE Dual Sensor Imaging System (K250684) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K152316 | iLab Ultrasound Imaging System | Boston Scientific | 2015 |
| K141453 | ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER | Lightlab Imaging, Inc. | 2014 |
Trace the full predicate network for K250684
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.