ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT

ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT is an FDA 510(k)-cleared medical device (K883372) manufactured by Ausonics Pty , Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 24, 1988. Regulation: 8.