510(k) K251401

PennPET Explorer Positron Emission Tomograph by Trustees of the University of Pennsylvania — Product Code KPS

K251401 is an FDA 510(k) premarket notification submitted by Trustees of the University of Pennsylvania for the device "PennPET Explorer Positron Emission Tomograph". The FDA issued a decision of Substantially Equivalent on November 25, 2025. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200.