4000 AU ULTRASOUND IMAGING SYSTEM

4000 AU ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K944485) manufactured by Biosound, 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 May 23, 1995. Regulation: 8.