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Medical Angiography X-ray Machine approved for marketing

CCFDIE| Updated: 2023-04-28

Recently, the innovative product "Medical Angiography X-ray Machine" of Shanghai United Imaging Healthcare Co., Ltd. is approved for marketing by China NMPA.

The product consists of high-voltage generator, X-ray tube assembly, beam limiter, filter grid, flat panel detector, rack, patient table, display, Displayer ceiling suspension, uVision component, touch panel, control module, control box, foot switch, hand switch, image acquisition workstation, video management workstation, image advanced processing workstation, 3D image processing workstation and accessories. It is applicable to X-ray fluoroscopy, photography, vascular subtraction image and tomography image for angiography and interventional surgery.

This product adopts 9-axis robot DSA, which can realize cone beam imaging of the whole abdomen and chest, and solves the problem of small  field of view upon the cone beam CT reconstruction of traditional cone beam CT. In addition, the product uses computer vision technology to realize one-click automatic cone beam CT scanning and one-click positioning, which can simplify the workflow of positioning and cone beam CT, reduce radiation exposure and intraoperative steps. Compared with the traditional medical angiography X-ray machine, this product can significantly expand field of view upon the cone beam CT reconstruction of traditional cone beam CT, reduce the operation steps, operation time and radiation dose of cone beam CT scanning, shorten the preparation time before imaging, and improve the surgical efficiency.

The NMPA will strengthen the post-marketing surveillance of the product to ensure the safety of medical devices used by patients.