uAngio AVIVA CX
Shanghai United Imaging Healthcare Co.,Ltd.The uAngio AVIVA CX is an advanced angiographic X-ray system designed to assist clinicians during diagnostic, interventional, and surgical procedures such as cardiac and neuro-angiography. It provides precise, intelligent image guidance with 2D and 3D imaging capabilities and software features such as camera-assisted recognition and voice control, helping to improve procedural accuracy and patient safety.
Intended Use
The system is used to perform image guidance in diagnostic, intervention and surgical procedures including cardiac angiography, neuro-angiography, vascular and non-vascular angiography, rotational angiography and whole body radiographic/fluoroscopic procedures.
Technology
The system generates X-rays via an X-ray tube and captures images using a flat panel detector, which are then digitally converted and enhanced through image post-processing. Key components include a C-arm stand, patient table, generator, collimator, and software for patient administration, 2D&3D image viewing, and advanced features such as camera-assisted recognition (uSpace) and voice control (uLingo).
Performance
Performance testing included non-clinical bench tests and clinical image evaluations. Bench tests verified C-arm positioning accuracy, image quality of cone-beam CT (CBCT), DSA dynamic range and contrast sensitivity, image registration accuracy, neuro image registration, stitching algorithm, and software features (uSpace and uLingo). Clinical evaluation involved assessment of real patient images by radiologists, confirming image quality adequate for diagnosis and intervention.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/30/2024
6 months - 2
FDA Approval
4/28/2025
Other devices from Shanghai United Imaging Healthcare Co.,Ltd.
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