Vivid T8, Vivid T9

Vivid T8, Vivid T9 is an FDA 510(k)-cleared medical device (K181934) manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. 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 5, 2018. Regulation: 8.