注册证编号国械注进20203060333
产品名称数字乳腺X射线摄影系统Mammography System
型号规格Selenia Dimensions
结构及组成/主要组成成分该产品由机架、高压发生器、高压逆变器、X射线管、X射线管套、限束器、数字探测器、采集工作站、预览显示器、脚踏开关、附件和选件组成，详见产品技术要求。
适用范围/预期用途该产品临床用于数字乳腺X射线检查，可提供二维摄影图像、三维体层图像、二维合成图像。三维体层图像和二维合成图像均不可单独用于临床诊断。
Registration Certificate No.: gxzz 20203060333
Product name digital mammography system
Model ａnd specification Selenia dimensions
Structure ａnd composition / main components the product is composed of frame, high voltage generator, high voltage inverter, X-ray tube, X-ray tube sleeve, beam limiter, digital detector, acquisition workstation, preview display, foot switch, accessories ａnd options. See the product technical requirements for details.
Scope of application / intended use this product is clinically used for digital breast X-ray examination ａnd can provide two-dimensional photographic images, three-dimensional tomography images ａnd two-dimensional synthetic images. Three dimensional tomography images ａnd two-dimensional synthetic images can not be used for clinical diagnosis alone.
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更新时间：2024/3/20 12:32:06
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