510(k) K013848

U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 by U-Systems, Inc. — Product Code IYN

K013848 is an FDA 510(k) premarket notification submitted by U-Systems, Inc. for the device "U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000". The FDA issued a decision of Substantially Equivalent on April 8, 2002. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. U-Systems, Inc. has at least 5 other 510(k) clearances on record.