OptiCross X, 40 MHz Coronary Imaging Catheter

OptiCross X, 40 MHz Coronary Imaging Catheter is an FDA 510(k)-cleared medical device (K161125) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2016. Regulation: 8.