510(k) K082656

MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT by Fukuda Denshi USA, Inc. — Product Code IYN

K082656 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT". The FDA issued a decision of Substantially Equivalent on September 30, 2008. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.