510(k) K253844

AnyScan 3.0 NM Scanner Family by Mediso Medical Imaging Systems, Ltd. — Product Code KPS

K253844 is an FDA 510(k) premarket notification submitted by Mediso Medical Imaging Systems, Ltd. for the device "AnyScan 3.0 NM Scanner Family". The FDA issued a decision of Substantially Equivalent on December 30, 2025. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200.