FDA Radiology AI Devices

The ACUSON Sequoia and ACUSON Origin Diagnostic Ultrasound Systems by Siemens are advanced ultrasound imaging devices used by clinicians to visualize internal structures of the body in real-time. They help in diagnosing a variety of conditions by providing high-quality ultrasonic images, aiding patient care through non-invasive and versatile imaging.

The Biograph Trinion is a combined PET/CT imaging system designed to provide high-resolution fusion of metabolic and anatomical information. It assists healthcare professionals in detecting, diagnosing, staging, and managing diseases such as cancer, cardiovascular disorders, and neurological conditions. The system also supports radiotherapy planning and interventional procedures, enhancing diagnostic accuracy and patient care.

The Cios Spin is a mobile fluoroscopic C-arm X-ray system designed for use in surgical environments. It enables clinicians to acquire detailed X-ray images during various procedures such as orthopedic, vascular, neurologic, and emergency room interventions. The system provides 3D image acquisition capabilities and integrates with navigation software to help clinicians accurately visualize anatomical structures, thereby enhancing procedural precision and patient care.

The Cios Alpha and Cios Flow devices by Siemens Medical Solutions USA are advanced interventional fluoroscopic X-ray systems. They provide real-time X-ray imaging to assist clinicians during interventional procedures, improving visualization and guidance for better patient outcomes.

The syngo.via MI Workflows, including Scenium and syngo MBF, are Siemens software tools designed to assist radiologists by automating the processing of medical images, improving workflow efficiency and potentially supporting diagnosis through advanced image analysis.

The SOMATOM go series by Siemens Medical Solutions USA, Inc., comprises advanced CT scanner systems used in radiology to produce detailed cross-sectional images of the body. These devices assist clinicians by providing high-quality computed tomography images that support diagnosis and treatment planning for various medical conditions.

The Biograph Vision and Biograph mCT PET/CT systems by Siemens are advanced imaging devices combining positron emission tomography (PET) and computed tomography (CT). These systems help clinicians detect and diagnose various conditions by providing detailed molecular and anatomical images, facilitating better patient management.

syngo.CT LVO Detection is an AI-powered post-processing software that analyzes CT angiography images of the brain to help clinicians prioritize cases by detecting suspected large vessel occlusions in specific brain vessels. It aids in triage but is not used for standalone diagnosis or altering images, thereby assisting medical professionals in managing stroke patients more efficiently.

The NAEOTOM Alpha series by Siemens is a computed tomography (CT) scanner system that produces detailed cross-sectional images using X-rays. These images aid clinicians in diagnosis, treatment, radiation therapy planning, and interventions, including low-dose lung cancer screening for high-risk populations. The system uses advanced software for image reconstruction and supports various post-processing applications to deliver clear and precise imaging for multiple clinical uses.

syngo.CT Dual Energy is a post-processing software application for CT scans that uses dual-energy imaging techniques combining low and high energy X-ray spectra to enhance visualization of different materials in the body. It helps clinicians by providing advanced imaging features for better evaluation of anatomical structures and pathologies, including brain hemorrhage visualization, lung perfusion, kidney stone analysis, and more, improving diagnostic accuracy without requiring additional scans.