FDA Radiology AI Devices

The ACUSON Sequoia Diagnostic Ultrasound System family by Siemens Medical Solutions includes multi-purpose, software-controlled ultrasound systems designed to provide detailed images and measurements from inside the body. These systems support various clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, among others. They assist clinicians by offering advanced imaging modes such as 2D, Doppler, elastography, and 3D/4D volume imaging, as well as specialized tools like Ultrasonically-Derived Fat Fraction (UDFF) for managing hepatic steatosis. The systems deliver real-time imaging and measurements to help diagnose and manage a wide range of conditions effectively.

The ACUSON Sequoia, Sequoia Select, and Origin are advanced multi-purpose diagnostic ultrasound systems by Siemens, designed for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging. They incorporate AI-based software applications (AI Measure, AI Assist, 2D HeartAI, 4D HeartAI) to assist clinicians in cardiac imaging by automating measurements, image annotation, and analysis, thereby improving workflow and diagnostic confidence.