ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM

ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K001400) manufactured by Siemens Medical Solutions USA, 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 July 31, 2000. Regulation: 8.