510(k) K231731

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 by Mcgovern Medical School — Product Code KPS

K231731 is an FDA 510(k) premarket notification submitted by Mcgovern Medical School for the device "Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4". The FDA issued a decision of Substantially Equivalent on August 21, 2023. 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.