510(k) K233719

FDR Visionary Suite by Shimadzu Corporation — Product Code KPR

K233719 is an FDA 510(k) premarket notification submitted by Shimadzu Corporation for the device "FDR Visionary Suite". The FDA issued a decision of Substantially Equivalent on March 28, 2024. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Shimadzu Corporation has at least 8 other 510(k) clearances on record.