510(k) K251481

ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System by Siemens Medical Solutions USA, Inc. — Product Code IYN

K251481 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on August 20, 2025. 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. has at least 10 other 510(k) clearances on record.