510(k) K183235

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

K183235 is an FDA 510(k) premarket notification submitted by FUJIFILM Sonosite, Inc. for the device "SonoSite SII Ultrasound System". The FDA issued a decision of Substantially Equivalent on Feb 7, 2019. 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.