OPUSWAVE Dual Sensor Imaging System
K-Number: K250684 · 2025-07-02
Decision Date2025-07-02
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OPUSWAVE Dual Sensor Imaging System is a medical device manufactured by Terumo Cardiovascular Systems Thi Plant. It received FDA 510(k) clearance on 2025-07-02 under approval number K250684. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OPUSWAVE Dual Sensor Imaging System?
OPUSWAVE Dual Sensor Imaging System is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Terumo Cardiovascular Systems Thi Plant. The 510(k) number is K250684.
When was OPUSWAVE Dual Sensor Imaging System approved by the FDA?
OPUSWAVE Dual Sensor Imaging System received FDA 510(k) clearance on 2025-07-02, under approval number K250684.
What company makes OPUSWAVE Dual Sensor Imaging System?
OPUSWAVE Dual Sensor Imaging System is manufactured by Terumo Cardiovascular Systems Thi Plant.
What is the FDA product code for OPUSWAVE Dual Sensor Imaging System?
The FDA product code for OPUSWAVE Dual Sensor Imaging System is NQQ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.