510(k) K153464

FDR D-EVO flat Panel Detector System by Fujifilm Medical Systems U.S.A, Inc. — Product Code MQB

K153464 is an FDA 510(k) premarket notification submitted by Fujifilm Medical Systems U.S.A, Inc. for the device "FDR D-EVO flat Panel Detector System". The FDA issued a decision of Substantially Equivalent on April 8, 2016. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Fujifilm Medical Systems U.S.A, Inc. has at least 10 other 510(k) clearances on record.