SYNC-RX SYSTEM, MODEL AS00010

SYNC-RX SYSTEM, MODEL AS00010 is an FDA 510(k)-cleared medical device (K100849) manufactured by Sync-Rx, 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 May 20, 2010. Regulation: 8.