K260673

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

510(k) 号
K260673
器械名称
LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power
申请人
GE Medical Systems Ultrasound and Primary Care Diagnostics WI · US
产品代码
IYN — System, Imaging, Pulsed Doppler, Ultrasonic
批准日期
2026-03-24
受理日期
2026-03-02
决定
Substantially Equivalent
审查途径
Traditional
咨询委员会
Radiology
510(k) Summary(FDA 官方 PDF): K260673.pdf
FDA 官方记录: K260673
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。