510(k) K230162

uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis by Shanghai United Imaging Healthcare Co., Ltd. — Product Code JAK

K230162 is an FDA 510(k) premarket notification submitted by Shanghai United Imaging Healthcare Co., Ltd. for the device "uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis". The FDA issued a decision of Substantially Equivalent on August 1, 2023. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Shanghai United Imaging Healthcare Co., Ltd. has at least 10 other 510(k) clearances on record.