510(k) K121293

CS-SERIES-FP WITH 3030+OPTION by Omega Medical Imaging, LLC — Product Code JAA

K121293 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, LLC for the device "CS-SERIES-FP WITH 3030+OPTION". The FDA issued a decision of Substantially Equivalent on July 26, 2012. 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, LLC has at least 10 other 510(k) clearances on record.