510(k) K981280

CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS by Bayer Corp., Agfa Div. — Product Code IXW

K981280 is an FDA 510(k) premarket notification submitted by Bayer Corp., Agfa Div. for the device "CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS". The FDA issued a decision of Substantially Equivalent on April 30, 1998. The device falls under product code IXW (Processor, Radiographic-Film, Automatic), a Class II device regulated under 21 CFR 892.1900. Bayer Corp., Agfa Div. has at least 2 other 510(k) clearances on record.