ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER

ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER is an FDA 510(k)-cleared medical device (K870964) manufactured by Elscint, 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 12, 1987. Regulation: 8.