510(k) K023020

AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE by Agfa Corp. — Product Code IXA

K023020 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE". The FDA issued a decision of Substantially Equivalent on September 26, 2002. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Agfa Corp. has at least 10 other 510(k) clearances on record.