FDA 510(k)

EchoPAC 软件仅限 / EchoPAC 插件

K号: K251342 · 2025-07-16

申请人GE Medical Systems Ultrasound and Primary Care Diagnostics

决定日期2025-07-16

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

EchoPAC Software Only / EchoPAC Plug-in is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-07-16 under 510(k) number K251342. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EchoPAC Software Only / EchoPAC Plug-in?

EchoPAC Software Only / EchoPAC Plug-in is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251342.

When did EchoPAC Software Only / EchoPAC Plug-in receive FDA 510(k) clearance?

EchoPAC Software Only / EchoPAC Plug-in received FDA 510(k) clearance on 2025-07-16, under 510(k) number K251342.

Who is the listed applicant for EchoPAC Software Only / EchoPAC Plug-in?

FDA 510(k)记录将GE医疗系统超声和初级护理诊断列为申请人。这本身并不足以确立设备制造商。

What is the FDA product code for EchoPAC Software Only / EchoPAC Plug-in?

The FDA product code for EchoPAC Software Only / EchoPAC Plug-in is QIH.

列明GE Medical Systems Ultrasound and Primary Care Diagnostics为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261623EchoPAC软件仅用 / EchoPAC插件（v211）K261313Vivid 探索者/Vivid 高级/Vivid 焦点 K261835LOGIQ Focus K260398LOGIQ e K260673LOGIQ 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 K253370LOGIQ Totus

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官方来源

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