HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM

HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K980860) manufactured by Atlantis Diagnostics Intl., 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 April 1, 1998. Regulation: 8.