510(k) K233613

ACUSON SC2000 Diagnostic Ultrasound System by Siemens Medical Solutions USA, Inc. — Product Code IYO

K233613 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "ACUSON SC2000 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Jun 12, 2024. 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. has at least 10 other 510(k) clearances on record.