510(k) K060440

CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER by Codonics, Inc. — Product Code LMC

K060440 is an FDA 510(k) premarket notification submitted by Codonics, Inc. for the device "CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER". The FDA issued a decision of Substantially Equivalent on March 16, 2006. 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.