510(k) K081121

MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM by Siemens Medical Solutions USA, Inc., Ultrasound DI — Product Code IYO

K081121 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI for the device "MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 4, 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.