510(k) K080760

ACUSON X300 ULTRASOUND SYSTEM by Siemens Medical Solutions USA, Inc., Ultrasound DI — Product Code IYN

K080760 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI for the device "ACUSON X300 ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 25, 2008. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Siemens Medical Solutions USA, Inc., Ultrasound DI has 10 other 510(k) clearances on record.