ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE are diagnostic ultrasound systems that transmit, receive, and process ultrasound echo data to create images and measurements of internal body structures. They are intended for use by trained healthcare professionals in clinical settings for applications including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging, with specialized support for liver elastography and intracardiac catheter guidance.

Software version VC10 introduces AI Measure and AI Assist workflow integration for automatic measurement label launching, Liver Elastography optimization across shear wave elastography modes (pSWE, auto pSWE, 2D SWE), addition of ultrasound attenuation coefficient to UDFF display, enhanced calculation features for head and abdominal circumference, heart rate measurement entry capability, and transducer imaging quality improvements for DAX and 8V3 transducers.

IEC 62359 (thermal and mechanical indices), AAMI ES 60601-1:2005 (general safety and performance), IEC 60601-1-2 Edition 4.0 (electromagnetic disturbances), IEC 60601-2-37 Edition 2.1 2015 (ultrasonic medical diagnostic equipment), ISO 10993-1 (biocompatibility), IEC 62304 (software lifecycle), ISO 13485:2016 (quality management), and FDA February 2023 Ultrasound Guidance document.

The subject devices have the same intended use, indications for use, use environment, and fundamental technological characteristics as the predicate device (K242523). The improvements are software enhancements and workflow optimizations that do not change the acoustic output, fundamental operating principles, or safety profile. Phantom testing of the liver elastography optimization met all acceptance criteria for accuracy and variability, demonstrating the modifications do not raise new or different questions of safety and effectiveness.