510(k) K182834

CS-series-FP with Optional ROI Accessory CA-100S by Omega Medical Imaging, LLC — Product Code JAA

K182834 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, LLC for the device "CS-series-FP with Optional ROI Accessory CA-100S". The FDA issued a decision of Substantially Equivalent on March 29, 2019. 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.