510(k) K030763

DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM by Diagnostic Ultrasound Corp. — Product Code IYO

K030763 is an FDA 510(k) premarket notification submitted by Diagnostic Ultrasound Corp. for the device "DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on March 26, 2003. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Diagnostic Ultrasound Corp. has at least 10 other 510(k) clearances on record.