510(k) K232569

CAREMIBRAIN by General Equipment For Medical Imaging, S.A. — Product Code KPS

K232569 is an FDA 510(k) premarket notification submitted by General Equipment For Medical Imaging, S.A. for the device "CAREMIBRAIN". The FDA issued a decision of Substantially Equivalent on September 21, 2023. 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, S.A. has at least 3 other 510(k) clearances on record.