Vivid E80/ Vivid E90/ Vivid E95

Vivid E80/ Vivid E90/ Vivid E95 is an FDA 510(k)-cleared medical device (K202658) 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 March 4, 2021. Regulation: 8.