510(k) K942561

FUJI FCR IMAGE PROCESSING UNIT IP-U515 by Fujifilm Medical System U.S.A., Inc. — Product Code IXK

K942561 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJI FCR IMAGE PROCESSING UNIT IP-U515". The FDA issued a decision of Substantially Equivalent on December 23, 1994. The device falls under product code IXK (System, Imaging, X-Ray, Electrostatic), a Class II device regulated under 21 CFR 892.1630. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.