Sonosite LX and Sonosite PX Ultrasound Systems

Sonosite LX and Sonosite PX Ultrasound Systems is an FDA 510(k)-cleared medical device (K251106) manufactured by FUJIFILM Sonosite, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 28, 2025. Regulation: 8.