Vivid S60N, Vivid S70N

Vivid S60N, Vivid S70N is an FDA 510(k)-cleared medical device (K223832) manufactured by Ge Medical System 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 15, 2023. Regulation: 8.