EchoPAC Software Only, EchoPAC Plug-In

EchoPAC Software Only, EchoPAC Plug-In is an FDA 510(k)-cleared medical device (K200852) 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 September 17, 2020. Regulation: 8.