510(k) K251106

Sonosite LX and Sonosite PX Ultrasound Systems by FUJIFILM Sonosite, Inc. — Product Code IYN

K251106 is an FDA 510(k) premarket notification submitted by FUJIFILM Sonosite, Inc. for the device "Sonosite LX and Sonosite PX Ultrasound Systems". The FDA issued a decision of Substantially Equivalent on Aug 29, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. FUJIFILM Sonosite, Inc. has at least 10 other 510(k) clearances on record.