# K250684: OPUSWAVE Dual Sensor Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Thi Plant
- Decided: Jul 2, 2025 after 118 days
- Product code: NQQ (System, Imaging, Optical Coherence Tomography (Oct))
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921750 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152316: iLab Ultrasound Imaging System, Boston Scientific (2015) Summary page 5.
- K141453: Ilumien Optis, Dragonfly Optis Imaging Catheter, Lightlab Imaging, Inc. (2014) Summary page 5.

## Indications for use
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

Source page: https://510kreport.com/device/K250684
Methodology: https://510kreport.com/methodology