510(k) K973802

SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM by Shimadzu Medical Systems — Product Code IYO

K973802 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 1998. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.