510(k) K062647

E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 by Omega Medical Imaging, Inc. — Product Code OWB

K062647 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, Inc. for the device "E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50". The FDA issued a decision of Substantially Equivalent on October 20, 2006. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Omega Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.