510(k) K911584

DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 by Pie Medical Equipment B.V. — Product Code IYO

K911584 is an FDA 510(k) premarket notification submitted by Pie Medical Equipment B.V. for the device "DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480". The FDA issued a decision of Substantially Equivalent on October 24, 1991. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Pie Medical Equipment B.V. has at least 7 other 510(k) clearances on record.