510(k) K183575

ACUSON S3000, S2000 Diagnostic Ultrasound System by Siemens Healthineers — Product Code IYN

K183575 is an FDA 510(k) premarket notification submitted by Siemens Healthineers for the device "ACUSON S3000, S2000 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on March 20, 2019. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Siemens Healthineers has at least 6 other 510(k) clearances on record.