510(k) K152138

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

K152138 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FDR D-EVO GL Flat Panel Detector System". The FDA issued a decision of Substantially Equivalent on November 5, 2015. 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 System U.S.A., Inc. has at least 10 other 510(k) clearances on record.