HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K034003) manufactured by Philips Ultrasound, 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 January 7, 2004. Regulation: 8.