UltraGuideCTR® image guided soft tissue release system

UltraGuideCTR® image guided soft tissue release system is an FDA 510(k)-cleared medical device (K252594) manufactured by Sonex Health. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 28, 2025. Regulation: 8.