510(k) K230800

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 by GEMSS HEALTHCARE CO., LTD. — Product Code KPR

K230800 is an FDA 510(k) premarket notification submitted by GEMSS HEALTHCARE CO., LTD. for the device "XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50". The FDA issued a decision of Substantially Equivalent on November 2, 2023. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. GEMSS HEALTHCARE CO., LTD. has at least 1 other 510(k) clearance on record.