ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT

ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT is an FDA 510(k)-cleared medical device (K925627) 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 October 7, 1993. Regulation: 8.