EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System is an FDA 510(k)-cleared medical device (K211597) manufactured by Philips Medical Systems. 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 7, 2021. Regulation: 8.