uAngio AVIVA CX

The uAngio AVIVA CX is an Image-Intensified Fluoroscopic X-Ray System engineered to provide image guidance across various diagnostic, interventional, and surgical procedures, including cardiac, neuro, vascular, and whole-body applications. Its design incorporates advanced features like camera-assisted recognition (uSpace) and voice control (uLingo) to enhance operational efficiency, with its substantial equivalence to legally marketed systems confirmed through comprehensive non-clinical and clinical image evaluations.

The uAngio AVIVA CX, an Image-Intensified Fluoroscopic X-Ray System developed by Shanghai United Imaging Healthcare Co.,Ltd., has received an official determination of substantial equivalence to legally marketed systems. This regulatory clearance, issued on April 28, 2025, permits the device to be marketed, contingent upon adherence to general controls and other applicable regulatory provisions, including requirements for registration, labeling, good manufacturing practices, and adverse event reporting. Designed to provide image guidance for a wide array of diagnostic, interventional, and surgical procedures, encompassing cardiac, neuro, vascular, and whole-body radiographic/fluoroscopic applications, the uAngio AVIVA CX integrates cutting-edge features such as uSpace for camera-assisted recognition and uLingo for voice control to optimize operational efficiency. Both non-clinical testing and clinical image evaluations confirmed the system's compliance with essential safety and performance standards, verifying that its image quality is suitable for its intended uses and that its technological characteristics do not compromise safety or effectiveness compared to existing systems.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific clinical scenarios were covered in the clinical image evaluations, and how did the uAngio AVIVA CX perform compared to predicate devices in those specific contexts?; Can detailed performance data for uSpace and uLingo be provided, particularly regarding their impact on operational efficiency and user workflow during complex procedures?; What are the long-term safety and performance profiles of the uAngio AVIVA CX system, especially concerning radiation dose management for both patients and operators?; Beyond general controls, are there any unique labeling requirements or specific training protocols recommended for the uAngio AVIVA CX given its advanced features like voice control?; How does the system's image quality compare quantitatively (e.g., spatial resolution, contrast-to-noise ratio) against other premium image-intensified fluoroscopic systems on the market?