Corin Optimized Positioning System (OPS) Plan

Corin Optimized Positioning System (OPS) Plan is an FDA 510(k)-cleared medical device (K183038) 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 November 25, 2018. Regulation: 8.