Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 is an FDA 510(k)-cleared medical device (K252328) 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 November 23, 2025. Regulation: 8.