MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE

MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE is an FDA 510(k)-cleared medical device (K902005) manufactured by Omega Medical Imaging, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 19, 1990. Regulation: 8.