510(k) K013686

KODAK DIRECTVIEW TABLETOP CASSETTE by Eastman Kodak Company — Product Code IXA

K013686 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK DIRECTVIEW TABLETOP CASSETTE". The FDA issued a decision of Substantially Equivalent on December 7, 2001. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Eastman Kodak Company has at least 10 other 510(k) clearances on record.