TeraRecon Cardiovascular.Calcification.CT

TeraRecon Cardiovascular.Calcification.CT is an FDA 510(k)-cleared medical device (K250288) manufactured by Terarecon,Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 2025. Regulation: 8.