510(k) K202160

Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System by FUJIFILM Sonosite, Inc. — Product Code IYN

K202160 is an FDA 510(k) premarket notification submitted by FUJIFILM Sonosite, Inc. for the device "Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System". The FDA issued a decision of Substantially Equivalent on Sep 1, 2020. 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.