510(k) K965223

RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM by Endosonics Corp. — Product Code IYO

K965223 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 29, 1998. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Endosonics Corp. has at least 10 other 510(k) clearances on record.