SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600

SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 is an FDA 510(k)-cleared medical device (K052447) manufactured by Analogic Corp.. 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 20, 2005. Regulation: 8.