HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K991671) manufactured by Advanced Technology Laboratories, 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 June 17, 1999. Regulation: 8.