510(k) K081148

SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER by Siemens Medical Solutions USA, Inc., Ultrasound DI — Product Code IYO

K081148 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI for the device "SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER". The FDA issued a decision of Substantially Equivalent on Dec 22, 2008. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Siemens Medical Solutions USA, Inc., Ultrasound DI has 10 other 510(k) clearances on record.