510(k) K902005

MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE by Omega Medical Imaging, Inc. — Product Code JAA

K902005 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, Inc. for the device "MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE". The FDA issued a decision of Substantially Equivalent on September 20, 1990. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Omega Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.