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FDA 510(k)

OPUSWAVE Dual Sensor Imaging System

K-Number: K250684 · 2025-07-02

ApplicantTerumo Cardiovascular Systems Thi Plant
Decision Date2025-07-02
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPUSWAVE Dual Sensor Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Thi Plant. It received FDA 510(k) clearance on 2025-07-02 under 510(k) 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. The listed applicant is Terumo Cardiovascular Systems Thi Plant. The 510(k) number is K250684.

When did OPUSWAVE Dual Sensor Imaging System receive FDA 510(k) clearance?

OPUSWAVE Dual Sensor Imaging System received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250684.

Who is the listed applicant for OPUSWAVE Dual Sensor Imaging System?

The FDA 510(k) record lists Terumo Cardiovascular Systems Thi Plant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPUSWAVE Dual Sensor Imaging System?

The FDA product code for OPUSWAVE Dual Sensor Imaging System is NQQ.

Related Devices (Code: NQQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICALK251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.K252851deepLive (OSP12 + DMS)Damae MedicalK251198HyperVue™ SoftwareSpectrawave, Inc.K242924OPXION Optical Skin Viewer (OPXSV1-01F)Opxion Technology, Inc.

Official Source

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