uPMR 790
K号: K234154 · 2024-05-24
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器械摘要
uPMR 790 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 2024-05-24 under 510(k) number K234154. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the uPMR 790?
uPMR 790 is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K234154.
When did uPMR 790 receive FDA 510(k) clearance?
uPMR 790 received FDA 510(k) clearance on 2024-05-24, under 510(k) number K234154.
Who is the listed applicant for uPMR 790?
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 uPMR 790?
The FDA product code for uPMR 790 is OUO.
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：OUO）
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。
K253963Cubresa 脑PETCubresa, Inc.K253023BIOGRAPH 一号Siemens Healthineers AGK222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K213709SIGNA PET/MRGe Medical Systems, LLCK200213Biograph mMR带syngo MR E11P-AP01系统软件Siemens Medical Solutions USA, Inc.K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.
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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