DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING

DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING is an FDA 510(k)-cleared medical device (K812014) 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 September 15, 1981. Regulation: 8.