510(k) K202679

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 by Mcgovern Medical School — Product Code KPS

K202679 is an FDA 510(k) premarket notification submitted by Mcgovern Medical School for the device "Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3". The FDA issued a decision of Substantially Equivalent on April 12, 2021. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Mcgovern Medical School has at least 1 other 510(k) clearance on record.