K252018

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System

510(k) 号: K252018
器械名称: HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 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: 2026-01-05
受理日期: 2025-06-30
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Radiology

510(k) Summary（FDA 官方 PDF）： K252018.pdf

FDA 官方记录： K252018

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。