FDA Radiology AI Devices

The Soteria E-View is a fluoroscopic and radiographic X-ray imaging system designed for use in general and pediatric populations. It provides real-time imaging during interventional procedures, helping clinicians visualize patient anatomy effectively. It integrates advanced flat panel detector technology and radiation safety controls to reduce exposure while delivering high-quality images for diagnostic and interventional use.

The Adora DRFi is a ceiling suspended, universal X-ray system designed for diagnostic radiography and fluoroscopy. It supports a wide range of whole-body X-ray examinations in both adult and pediatric patients and features a flat panel detector for direct radiography and radioscopy. The system improves ergonomics and workflow while enabling imaging in various patient positions including supine, standing, sitting, wheelchair, or stretcher. It is intended for use by trained healthcare professionals and is not for mammography.

The XIDF-AWS801 Angio Workstation (Alphenix Workstation), V9.5, by Canon Medical Systems is a medical imaging system used alongside interventional angiography equipment. It provides 2D and 3D imaging to assist clinicians in visualizing blood vessels throughout the body during catheter procedures. The device incorporates AI deep learning software to improve the detection and stabilization of stent markers, enhancing image clarity and aiding in diagnosis and treatment planning.

The CS-series-FP Radiographic / Fluoroscopic System with the optional CA-100S / FluoroShield ROI Assembly is an advanced fluoroscopic X-ray system that automatically manages and reduces radiation exposure by focusing on a configurable region of interest (ROI) during imaging. It blends high-resolution live imaging of the ROI with lower-exposure peripheral imaging, thus improving image quality and reducing unnecessary radiation dose to both patients and medical staff during interventional procedures.

The DR 800 with MUSICA Dynamic by Agfa HealthCare is an advanced fluoroscopic X-ray system designed for dynamic imaging of various body parts, such as gastrointestinal and urogenital tract examinations and angiography. It replaces traditional image intensifier technology with flat-panel digital detectors and incorporates MUSICA Dynamic software for enhanced image processing, improving image quality and aiding clinicians in accurate diagnosis while supporting pediatric and adult imaging needs.