510(k) K240827

SET-5002 by Shimadzu Corporation Medical Systems Division — Product Code KPS

K240827 is an FDA 510(k) premarket notification submitted by Shimadzu Corporation Medical Systems Division for the device "SET-5002". The FDA issued a decision of Substantially Equivalent on May 24, 2024. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Shimadzu Corporation Medical Systems Division has at least 1 other 510(k) clearance on record.