Vivid T9/Vivid T8

Vivid T9/Vivid T8 is an FDA 510(k)-cleared medical device (K243628) 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 February 10, 2025. Regulation: 8.