OEC One CFD
Ge Hualun Medical Systems Co. , Ltd.The OEC One CFD is a mobile C-arm X-ray system designed to provide fluoroscopic and digital spot images during various diagnostic, interventional, and surgical procedures in adults and pediatric patients. It includes advanced features like deep learning-based Trajectory Pointer to aid in positioning Kirschner-wires, and Image Stitching to create composite images for improved visualization. These tools help clinicians better visualize anatomy and aid precise interventions, improving clinical workflow and patient care.
Intended Use
The product is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures such as orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
Technology
Mobile C-arm X-ray system with a flat panel detector and X-ray source mounted on a C-shaped arm. Employs CMOS flat panel detectors for image acquisition. Includes options for Image Stitching and a deep learning-based Trajectory Pointer software feature to improve imaging and procedural guidance.
Performance
The deep learning Trajectory Pointer feature was tested on 3078 images, with a success rate over 97%, exceeding the minimal accuracy target. Image Stitching and overall image quality were assessed using anthropomorphic phantoms with simulated bone and vascular structures, showing satisfactory performance. The system meets applicable IEC and FDA standards and underwent comprehensive non-clinical validation including software and safety testing.
Predicate Devices
No predicate devices specified
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