IU22 DIAGNOSTIC ULTRASOUND SYSTEM

IU22 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K130499) 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 June 17, 2013. Regulation: 8.