510(k) K170315

Acuson SC2000 Diagnostic Ultrasound System by Siemens Medi Cal Solutions, Inc. — Product Code IYN

K170315 is an FDA 510(k) premarket notification submitted by Siemens Medi Cal Solutions, Inc. for the device "Acuson SC2000 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on April 4, 2017. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Siemens Medi Cal Solutions, Inc. has at least 10 other 510(k) clearances on record.