510(k) K152369

ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System by Siemens Medical Solutions USA, Inc. Ultrasound Group — Product Code IYN

K152369 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. Ultrasound Group for the device "ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System". The FDA issued a decision of Substantially Equivalent on Oct 6, 2015. 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 Group has 2 other 510(k) clearances on record.