510(k) K931002

FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS by Fujifilm Medical System U.S.A., Inc. — Product Code IXK

K931002 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS". The FDA issued a decision of Substantially Equivalent on June 8, 1993. 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.