510(k) K070834

CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) by Omega Medical Imaging, Inc. — Product Code OWB

K070834 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, Inc. for the device "CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)". The FDA issued a decision of Substantially Equivalent on May 18, 2007. 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.