510(k) K915647

DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250 by Pie Medical Equipment B.V. — Product Code ITX

K915647 is an FDA 510(k) premarket notification submitted by Pie Medical Equipment B.V. for the device "DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250". The FDA issued a decision of Substantially Equivalent on November 9, 1992. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Pie Medical Equipment B.V. has at least 7 other 510(k) clearances on record.