CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is an FDA 510(k)-cleared medical device (K162329) manufactured by Philips Health Care. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2016. Regulation: 8.