510(k) K213763

Sonosite PX Ultrasound System by FUJIFILM Sonosite, Inc. — Product Code IYN

K213763 is an FDA 510(k) premarket notification submitted by FUJIFILM Sonosite, Inc. for the device "Sonosite PX Ultrasound System". The FDA issued a decision of Substantially Equivalent on Dec 27, 2021. 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.