FDA 510(k)

uMI Panvivo（uMI Panvivo）；uMI Panvivo（uMI Panvivo S）

K号: K251839 · 2025-07-17

申请人Shanghai United Imaging Healthcare Co., Ltd.

决定日期2025-07-17

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K251839. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)?

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K251839.

When did uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) receive FDA 510(k) clearance?

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) received FDA 510(k) clearance on 2025-07-17, under 510(k) number K251839.

Who is the listed applicant for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)?

FDA 510(k)记录将上海联影医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)?

The FDA product code for uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is KPS.

列明Shanghai United Imaging Healthcare Co., Ltd.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。

K253726uAngio AVIVA CX K261427uMI Panvivo（uMI Panvivo M）K260113uMR Astra K253077uOmnispace.MR K260524uMI Panvivo（uMI Panvivo LS）；uMI Panvivo（uMI Panvivo）；uMI Panvivo（uMI Panvivo S）；uMI Panvivo（uMI Panvivo EX）；uMI Panvivo（uMI Panvivo ES）K253564uMI Panvivo（uMI Panvivo）；uMI Panvivo（uMI Panvivo S）；uMI Panvivo（uMI Panvivo EX）；uMI Panvivo（uMI Panvivo ES）

查看所有 85 个设备 →

相关器械（代码：KPS）

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。

官方来源

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