Vivid E80, Vivid E90, Vivid E95

Vivid E80, Vivid E90, Vivid E95 is an FDA 510(k)-cleared medical device (K173341) manufactured by GE Medical Systems. 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 1, 2017. Regulation: 8.