K243226

Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)

510(k) 号: K243226
器械名称: Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)
申请人: Leltek, Inc. TW
产品代码: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
批准日期: 2025-05-08
受理日期: 2024-10-08
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Radiology

也可从 FDA 官方下载： K243226.pdf

FDA 官方记录： K243226

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。