OPUSWAVE Dual Sensor Imaging System

OPUSWAVE Dual Sensor Imaging System is an FDA 510(k)-cleared medical device (K250684) manufactured by Terumo Cardiovascular Systems Thi Plant. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 2025. Regulation: 8.