510(k) K193225

KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography by Konica Minolta Healthcare Americas, Inc. — Product Code KPR

K193225 is an FDA 510(k) premarket notification submitted by Konica Minolta Healthcare Americas, Inc. for the device "KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography". The FDA issued a decision of Substantially Equivalent on January 15, 2020. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Konica Minolta Healthcare Americas, Inc. has at least 5 other 510(k) clearances on record.