医疗图像后处理软件（uOmnispace.CT）
K号: K242624 · 2025-05-14
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器械摘要
Medical Image Post-processing Software (uOmnispace.CT) 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 2025-05-14 under 510(k) number K242624. 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 Medical Image Post-processing Software (uOmnispace.CT)?
Medical Image Post-processing Software (uOmnispace.CT) is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K242624.
When did Medical Image Post-processing Software (uOmnispace.CT) receive FDA 510(k) clearance?
Medical Image Post-processing Software (uOmnispace.CT) received FDA 510(k) clearance on 2025-05-14, under 510(k) number K242624.
Who is the listed applicant for Medical Image Post-processing Software (uOmnispace.CT)?
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 Medical Image Post-processing Software (uOmnispace.CT)?
The FDA product code for Medical Image Post-processing Software (uOmnispace.CT) is QIH.
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：QIH）
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
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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