510(k) K171755

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System by Omega Medical Imaging, LLC — Product Code OWB

K171755 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, LLC for the device "CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System". The FDA issued a decision of Substantially Equivalent on February 9, 2018. 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, LLC has at least 10 other 510(k) clearances on record.