510(k) K243881

HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 by Bracco Diagnostics, Inc. — Product Code KPS

K243881 is an FDA 510(k) premarket notification submitted by Bracco Diagnostics, Inc. for the device "HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4". The FDA issued a decision of Substantially Equivalent on March 3, 2025. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Bracco Diagnostics, Inc. has at least 1 other 510(k) clearance on record.