510(k) K991671

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM by Advanced Technology Laboratories, Inc. — Product Code IYO

K991671 is an FDA 510(k) premarket notification submitted by Advanced Technology Laboratories, Inc. for the device "HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on June 18, 1999. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Advanced Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.