510(k) K021054

CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER by Codonics, Inc. — Product Code LMC

K021054 is an FDA 510(k) premarket notification submitted by Codonics, Inc. for the device "CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER". The FDA issued a decision of Substantially Equivalent on May 9, 2002. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Codonics, Inc. has at least 6 other 510(k) clearances on record.