FDA Radiology AI Devices

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.