510(k) K050092

R605 FACS COLLIMETER by Omega Medical Imaging, Inc. — Product Code IZW

K050092 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, Inc. for the device "R605 FACS COLLIMETER". The FDA issued a decision of Substantially Equivalent on January 31, 2005. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Omega Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.