
Omega Medical Imaging, LLC
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CS-SERIES-FP WITH 3030+OPTION is an FDA 510(k)-cleared medical device (K121293) 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 July 25, 2012. Regulation: 8.