G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS

G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS is an FDA 510(k)-cleared medical device (K902984) manufactured by Electromek Diagnostic 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 October 25, 1990. Regulation: 8.