Voluson™ Performance 16; Voluson™ Performance 18

Voluson™ Performance 16; Voluson™ Performance 18 is an FDA 510(k)-cleared medical device (K250543) 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 May 28, 2025. Regulation: 8.