HeartSee Cardiac P.E.T. Processing Software

HeartSee Cardiac P.E.T. Processing Software is an FDA 510(k)-cleared medical device (K181343) manufactured by Bracco Diagnostics, 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 June 11, 2018. Regulation: 8.