LOGIQ E9, LOGIQ E9 XDClear 2.0

LOGIQ E9, LOGIQ E9 XDClear 2.0 is an FDA 510(k)-cleared medical device (K163077) 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 November 16, 2016. Regulation: 8.