510(k) K082142

ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM by Siemens Medical Solutions USA, Inc., Ultrasound DI — Product Code IYN

K082142 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI for the device "ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 13, 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.