Optimized Positioning System (OPS) ReView

Optimized Positioning System (OPS) ReView is an FDA 510(k)-cleared medical device (K193042) manufactured by Corin USA. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2020. Regulation: 8.