HD11 DIAGNOSTIC ULTRASOUND SYSTEM

HD11 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K043535) 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 5, 2005. Regulation: 8.