510(k) K260595

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

K260595 is an FDA 510(k) premarket notification submitted by FUJIFILM Sonosite, Inc. for the device "Sonosite iLOOK Ultrasound System". The FDA issued a decision of Substantially Equivalent on Mar 10, 2026. 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.