510(k) K924012

FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE by Fujifilm Medical System U.S.A., Inc. — Product Code IXK

K924012 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE". The FDA issued a decision of Substantially Equivalent on October 16, 1992. 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.