K250110

Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);

510(k) 号: K250110
器械名称: Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);
申请人: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. CN
产品代码: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
批准日期: 2025-05-16
受理日期: 2025-01-16
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Radiology

PDF下载 510(k) Summary本站存档 · 0.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K250110.pdf

FDA 官方记录： K250110

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。