510(k) K053347

KODAK CARESTREAM PACS by Eastman Kodak Company — Product Code LLZ

K053347 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK CARESTREAM PACS". The FDA issued a decision of Substantially Equivalent on January 4, 2006. 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.