FDA Radiology AI Devices

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 ARTIS icono (VE40A) family and ARTIS pheno (VE40A) are advanced angiography systems that enable detailed imaging for diagnostic and interventional procedures. They support single-plane and biplane imaging with a motorized C-arm and flat panel detector, allowing clinicians to perform cardiac, neuro, general angiography, and image-guided surgeries. The systems provide 2D and 3D imaging capabilities, including 3D reconstruction software (DynaCT), which helps clinicians visualize both hard and soft tissues for diagnosis, surgical planning, and treatment follow-up.