FDA Radiology AI Devices

The Alphenix INFX-8000V is an interventional fluoroscopic X-ray system designed by Canon Medical Systems Corporation. It provides real-time X-ray imaging to assist clinicians during interventional procedures, allowing enhanced visualization of anatomy and devices, thereby improving procedure accuracy and patient care.

Insight Enhanced™ DRF is a fluoroscopic X-ray system used in radiology to capture dynamic real-time images of the body, assisting clinicians in diagnosis and treatment by providing enhanced visualization during procedures.

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 Orthoscan TAU Mini C-Arm is a mobile fluoroscopic X-ray machine that provides real-time moving X-ray images. It helps clinicians with imaging during procedures, allowing better visualization and guidance for interventions.

The EXTRON series (EXTRON 3, EXTRON 5, EXTRON 7) are mobile fluoroscopic X-ray systems that provide high-quality, real-time X-ray images to support clinicians during emergency injury treatment, orthopedic surgery, neurosurgery, and other interventions. The system includes advanced image processing capabilities and enables saving and transferring images to hospital PACS, improving diagnosis and workflow in surgical settings.

The Zoom 7X Catheter, along with the Zoom Aspiration Tubing and Zoom POD Aspiration Tubing, is a sterile, single-use medical device designed to remove blood clots from large intracranial vessels in patients experiencing an acute ischemic stroke. It helps restore blood flow by aspirating the clot when connected to an aspiration pump, aiding clinicians in rapidly treating stroke and improving patient outcomes.

The Diagnostic X-ray System is a mobile fluoroscopic X-ray system with a C-arm and digital imaging capabilities. It is used by trained medical professionals for real-time imaging guidance during diagnostic, interventional, and surgical procedures, helping clinicians visualize inside the body with X-rays from various angles.

The MasteRad MiniX Mobile Digital Imaging System (Mini-X) is a portable fluoroscopic X-ray system designed for real-time imaging and guidance during diagnostic radiography and surgical procedures of the extremities. Its mobility and advanced imaging technology facilitate easy positioning and high-quality visualization to assist medical professionals in various clinical settings, except neonates and mammography.

Persona C HR is a mobile C-arm X-ray device used to provide real-time fluoroscopic imaging guidance during various diagnostic, interventional, and surgical procedures. It helps clinicians visualize patient anatomy with high-quality images to assist in precise and effective treatment, excluding pediatric patients.