510(k) K171303

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 by University Of Texas Medical School AT Houston, Texas — Product Code KPS

K171303 is an FDA 510(k) premarket notification submitted by University Of Texas Medical School AT Houston, Texas for the device "Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664". The FDA issued a decision of Substantially Equivalent on Sep 22, 2017. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200.