uDR Arria & uDR Aris
Shanghai United Imaging Healthcare Co., Ltd.The uDR Arria & uDR Aris are stationary digital X-ray imaging systems designed to acquire high-quality 2D X-ray images of various body parts to support radiologists and clinicians in diagnosing medical conditions. They include AI-assisted features like uVision for patient positioning and uAid for image quality assessment, helping improve clinical workflow and image quality control.
Intended Use
Digital Medical X-ray Imaging System is intended to acquire X-ray images of the human body by a qualified technician, including acquiring two-dimensional X-ray images of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not intended for mammography.
Technology
The system includes imaging chain components with enhanced processing technology for high image quality. It is equipped with high voltage generators, X-ray tube assemblies, flat panel detectors, manual/motorized collimators, and patient tables. AI features include uVision for automatic positioning via cameras and uAid for automated image quality assessment using deep learning.
Performance
Non-clinical tests verify compliance with safety and performance standards (e.g., IEC 60601 series). Clinical image evaluation with radiologist review confirms image quality sufficient for diagnosis. AI features uVision and uAid were tested using clinical data showing high accuracy in positioning and image quality classification, respectively.
Predicate Devices
No predicate devices specified
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