K250999

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

510(k) 号: K250999
器械名称: V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
申请人: Samsung Medison Co., Ltd. KR
产品代码: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
批准日期: 2025-07-18
受理日期: 2025-04-01
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Radiology

510(k) Summary（FDA 官方 PDF）： K250999.pdf

FDA 官方记录： K250999

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。