Optimized Positioning System (OPS) Insight

Optimized Positioning System (OPS) Insight is an FDA 510(k)-cleared medical device (K192656) 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 April 30, 2020. Regulation: 8.