510(k) K161631

MAMMI by General Equipment For Medical Imaging — Product Code KPS

K161631 is an FDA 510(k) premarket notification submitted by General Equipment For Medical Imaging for the device "MAMMI". The FDA issued a decision of Substantially Equivalent on July 28, 2016. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. General Equipment For Medical Imaging has at least 3 other 510(k) clearances on record.