PennPET Explorer Positron Emission Tomograph

PennPET Explorer Positron Emission Tomograph is an FDA 510(k)-cleared medical device (K251401) manufactured by Trustees of the University of Pennsylvania. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 24, 2025. Regulation: 8.