510(k) K142003

FDR D-EVO II FLAT PANEL DETECTOR SYSTEM by Fujifilm Medical System U.S.A., Inc. — Product Code MQB

K142003 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FDR D-EVO II FLAT PANEL DETECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on October 21, 2014. 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.