CS-series-FP with Optional ROI Accessory CA-100S

CS-series-FP with Optional ROI Accessory CA-100S is an FDA 510(k)-cleared medical device (K182834) 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 March 28, 2019. Regulation: 8.