510(k) K253564

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) by Shanghai United Imaging Healthcare Co., Ltd. — Product Code KPS

K253564 is an FDA 510(k) premarket notification submitted by Shanghai United Imaging Healthcare Co., Ltd. for the device "uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Shanghai United Imaging Healthcare Co., Ltd. has at least 10 other 510(k) clearances on record.