EchoPAC Software Only, EchoPAC Plug-in

EchoPAC Software Only, EchoPAC Plug-in is an FDA 510(k)-cleared medical device (K170847) manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. 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 13, 2017. Regulation: 8.