Cleared Traditional

K250684 - OPUSWAVE Dual Sensor Imaging System

K250684 is an FDA 510(k) clearance for OPUSWAVE Dual Sensor Imaging System, manufactured by Terumo Cardiovascular Systems Thi Plant. The device is a Class 2 Cardiovascular device with product code NQQ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K250684 · Terumo Cardiovascular Systems Thi Plant · Cardiovascular device
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Jul 2025
Decision
118d
Days
Class 2
Risk

K250684 is an FDA 510(k) clearance for the OPUSWAVE Dual Sensor Imaging System. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Thi Plant (Ann Arbor, US). The FDA issued a Cleared decision on July 2, 2025 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.1560 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Terumo Cardiovascular Systems Thi Plant devices

FDA 510(k) Submission Details - K250684

510(k) Number K250684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQQ Device Classification - Class 2, Special Controls

Product Code NQQ System, Imaging, Optical Coherence Tomography (oct)
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - NQQ System, Imaging, Optical Coherence Tomography (oct)

All 24
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K250684.
HyperVue™ Imaging System - Integrated
K253101 · Spectrawave, Inc. · Dec 2025
deepLive (OSP12 + DMS)
K252851 · Damae Medical · Oct 2025
HyperVue™ Software
K251198 · Spectrawave, Inc. · Jul 2025
OPXION Optical Skin Viewer (OPXSV1-01F)
K242924 · Opxion Technology, Inc. · Jun 2025
Cornaris Intravascular Imaging System (P80-E)
K242098 · Shenzhen Vivolight Medical Device & Technology Co., Ltd. · Apr 2025
Starlight Imaging Catheter
K243016 · Spectrawave, Inc. · Mar 2025