510(k) K092756

GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM by Ge Vingmed Ultrasound AS — Product Code ITX

K092756 is an FDA 510(k) premarket notification submitted by Ge Vingmed Ultrasound AS for the device "GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on September 28, 2009. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Ge Vingmed Ultrasound AS has at least 10 other 510(k) clearances on record.