CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) is an FDA 510(k)-cleared medical device (K191713) manufactured by Omega Medical Imaging, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 2019. Regulation: 8.