510(k) K030781

KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB by Eastman Kodak Company — Product Code LLZ

K030781 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB". The FDA issued a decision of Substantially Equivalent on May 29, 2003. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Eastman Kodak Company has at least 10 other 510(k) clearances on record.