510(k) K923990

FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE by Fujifilm Medical System U.S.A., Inc. — Product Code IXK

K923990 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE". The FDA issued a decision of Substantially Equivalent on December 17, 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.