Cleared Traditional

OPUSWAVE Dual Sensor Imaging System

K250684 · Terumo Cardiovascular Systems Thi Plant · Cardiovascular

Jul 2025

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K250684 is an FDA 510(k) clearance for the OPUSWAVE Dual Sensor Imaging System, a System, Imaging, Optical Coherence Tomography (oct) (Class II — Special Controls, product code NQQ), submitted by Terumo Cardiovascular Systems Thi Plant (Ann Arbor, US). The FDA issued a Cleared decision on July 2, 2025, 118 days after receiving the submission on March 6, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K250684 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2025
Decision Date	July 02, 2025
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	NQQ — System, Imaging, Optical Coherence Tomography (oct)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1560
Definition	This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.