510(k) K173816

NM/CT 850, NM/CT 860 by GE Healthcare — Product Code KPS

K173816 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "NM/CT 850, NM/CT 860". The FDA issued a decision of Substantially Equivalent on Apr 17, 2018. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. GE Healthcare has 168 other 510(k) clearances on record.