510(k) K961739

KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT by Kodak Health Imaging Systems, Inc. — Product Code LLZ

K961739 is an FDA 510(k) premarket notification submitted by Kodak Health Imaging Systems, Inc. for the device "KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT". The FDA issued a decision of Substantially Equivalent on November 14, 1996. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Kodak Health Imaging Systems, Inc. has at least 5 other 510(k) clearances on record.