K250214

Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)

510(k) 号: K250214
器械名称: Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
申请人: Edan Instruments, Inc. CN
产品代码: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
批准日期: 2025-02-20
受理日期: 2025-01-24
决定: Substantially Equivalent
审查途径: Traditional
标记: 第三方审查
咨询委员会: Radiology

PDF下载 510(k) Summary本站存档 · 1.8 MB · FDA 公有领域文件

也可从 FDA 官方下载： K250214.pdf

FDA 官方记录： K250214

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。