Vivid E80/ Vivid E90/ Vivid E95

Vivid E80/ Vivid E90/ Vivid E95 is an FDA 510(k)-cleared medical device (K200743) manufactured by Ge Medical Systems Ultrasound And. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2020. Regulation: 8.