510(k) K052355

AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS by U-Systems, Inc. — Product Code IYO

K052355 is an FDA 510(k) premarket notification submitted by U-Systems, Inc. for the device "AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS". The FDA issued a decision of Substantially Equivalent on September 14, 2005. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. U-Systems, Inc. has at least 5 other 510(k) clearances on record.