Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is an FDA 510(k)-cleared medical device (K231731) manufactured by Mcgovern Medical School. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 20, 2023. Regulation: 8.