Vivid S60N, Vivid S70N

Vivid S60N, Vivid S70N is an FDA 510(k)-cleared medical device (K170878) 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 June 13, 2017. Regulation: 8.