510(k) K093466

HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS by Hitachi Medical Systems America, Inc. — Product Code IYO

K093466 is an FDA 510(k) premarket notification submitted by Hitachi Medical Systems America, Inc. for the device "HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS". The FDA issued a decision of Substantially Equivalent on June 17, 2010. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Hitachi Medical Systems America, Inc. has at least 10 other 510(k) clearances on record.