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 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 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.

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.

The uAngio AVIVA CX is an advanced angiographic X-ray system designed to assist clinicians during diagnostic, interventional, and surgical procedures such as cardiac and neuro-angiography. It provides precise, intelligent image guidance with 2D and 3D imaging capabilities and software features such as camera-assisted recognition and voice control, helping to improve procedural accuracy and patient safety.

The Ziehm Solo FD is a mobile fluoroscopic X-ray imaging device designed for both adult and pediatric patients. It provides real-time pulsed and continuous fluoroscopic imaging to assist clinicians during diagnostic, interventional, and surgical procedures across various specialties such as orthopedics, neurology, vascular, and cardiac care. The device enhances visualization of anatomical structures, helping improve clinical outcomes through high-quality digital images and cine loops capture.

The Ziehm Vision RFD 3D is a medical imaging device that provides high-quality 2D and 3D fluoroscopic X-ray images during surgical and diagnostic procedures. It helps clinicians visualize complex anatomical structures such as bones, joints, and soft tissues in real-time, improving outcomes in orthopedic, neurological, trauma, and other surgeries. The system supports computer-assisted surgery by providing detailed imaging and C-arm positioning data, facilitating safer and more accurate interventions.

The Ziehm Vision RFD is a mobile fluoroscopy system with a flat panel detector used to provide real-time digital imaging during diagnostic and interventional surgical procedures. It helps clinicians visualize complex anatomical structures in various body regions including the spine, joints, and cardiovascular system, aiding in procedures such as cardiology, orthopedics, neurology, and more. The device offers advanced digital subtraction and cine imaging, enhancing image quality and surgical navigation accuracy to improve clinical outcomes for patients.

The MC2 Portable X-ray System by Oxos Medical is a handheld, portable X-ray device intended to help clinicians perform point-of-care imaging of joint and bone areas (extremities) outside of surgery. It uses advanced technologies including infrared tracking and LIDAR to position and ensure safe operation, producing high-quality images in single radiography, serial radiography, and fluoroscopic modes. The device connects wirelessly to tablets or monitors for image review and facilitates efficient orthopedic imaging in various clinical settings.