uMR 朱庇特
K号: K250246 · 2025-08-05
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器械摘要
uMR Jupiter 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 2025-08-05 under 510(k) number K250246. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the uMR Jupiter?
uMR Jupiter is a medical device that received FDA 510(k) clearance on 2025-08-05. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K250246.
When did uMR Jupiter receive FDA 510(k) clearance?
uMR Jupiter received FDA 510(k) clearance on 2025-08-05, under 510(k) number K250246.
Who is the listed applicant for uMR Jupiter?
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 uMR Jupiter?
The FDA product code for uMR Jupiter is LNH.
相关临床试验
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。
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 CXK261427uMI Panvivo（uMI Panvivo M）K260113uMR AstraK253077uOmnispace.MRK260524uMI 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）
相关器械（代码：LNH）
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。
K261283APERTO 明亮 MRI 系统Fujifilm CorporationK261758拥抱愿景新生儿MRI系统Aspect Imaging, Ltd.K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® 便携式MR成像® 系统Hyperfine, Inc.K254250MagicScan-1.5，GreenMR宁静1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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