uMR 680
K号: K222755 · 2023-02-16
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器械摘要
uMR 680 is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K222755. 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 680?
uMR 680 is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K222755.
When did uMR 680 receive FDA 510(k) clearance?
uMR 680 received FDA 510(k) clearance on 2023-02-16, under 510(k) number K222755.
Who is the listed applicant for uMR 680?
The FDA 510(k) record lists Shanghai United Imaging Intelligence Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for uMR 680?
The FDA product code for uMR 680 is LNH.
列明Shanghai United Imaging Intelligence 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。
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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