MCA-601, C-ARM MOBILE

MCA-601, C-ARM MOBILE is an FDA 510(k)-cleared medical device (K993896) manufactured by Medison Radiology Systems, 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 March 26, 2000. Regulation: 8.