Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is an FDA 510(k)-cleared medical device (K202679) 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 April 11, 2021. Regulation: 8.