510(k) K022517

USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY by U-Systems, Inc. — Product Code IYN

K022517 is an FDA 510(k) premarket notification submitted by U-Systems, Inc. for the device "USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY". The FDA issued a decision of Substantially Equivalent on December 24, 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.