uAngio AVIVA CX
Shanghai United Imaging Healthcare Co., Ltd.The uAngio AVIVA CX is an advanced angiographic X-ray system that assists clinicians with image guidance during diagnostic and surgical procedures. It incorporates artificial intelligence features to improve image quality and enhance the visibility of devices like stents, helping physicians perform complex interventions with greater precision and safety.
Intended Use
The system is used to perform image guidance in diagnostic, interventional and surgical procedures. Procedures that can be performed with the system include cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures.
Technology
A multi-component angiographic X-ray system with a flat panel detector, advanced image processing software, and several AI-powered features: (1) uStent and uStent Live for stent enhancement, which use automated stent marker tracking and image frame alignment to enhance device visualization; (2) VeraNF, a deep learning-based denoising function that improves signal-to-noise ratio by processing raw data; (3) additional functions like patient/admin interface, 2D/3D viewing, voice control, and camera-assisted recognition.
Performance
Performance was supported by extensive bench testing and clinical image evaluations: (1) uStent/uStent Live achieved >90% marker tracking success rate and >94.5% successful detection on bench tests, with inference times suitable for clinical workflow; (2) VeraNF image quality metrics met or exceeded requirements for spatial/contrast resolution, dynamic range, uniformity, motion blur, and patient dose rates; (3) Clinical evaluations included head-to-head and systematic reviews of the new algorithms and full clinical images, focusing on clarity and enhancement of stents, balloons, and general image quality across regions.
Predicate Devices
No predicate devices specified
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