FDA Radiology AI Devices

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems by Siemens are advanced diagnostic ultrasound devices that provide detailed imaging and signal data inside the body for clinical diagnosis. They are intended for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and pediatric imaging. These systems integrate AI-powered tools such as AI Abdomen for semi-automated view classification and measurement in abdominal ultrasound, and Trace AI for semi-automated measurements of anatomical structures in cardiac imaging, improving efficiency and accuracy for clinicians.

The syngo.via MI Workflows, including Scenium and syngo MBF, is a multi-modality software platform developed to assist healthcare professionals in viewing, manipulating, quantifying, and analyzing medical images from various imaging modalities, including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids physicians in radiotherapy treatment planning by harmonizing PET data and providing standardized analysis tools such as brain amyloid quantification.