510(k) K160674

Fujifilm Sonosite Vevo MD Imaging System by FUJIFILM Sonosite, Inc. — Product Code IYN

K160674 is an FDA 510(k) premarket notification submitted by FUJIFILM Sonosite, Inc. for the device "Fujifilm Sonosite Vevo MD Imaging System". The FDA issued a decision of Substantially Equivalent on Apr 19, 2016. 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.