MRI 动态分析 Plus
K号: K153039 · 2016-01-08
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器械摘要
MRI Dynamic Analysis Plus is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-01-08 under 510(k) number K153039. 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 MRI Dynamic Analysis Plus?
MRI Dynamic Analysis Plus is a medical device that received FDA 510(k) clearance on 2016-01-08. The listed applicant is Esaote, S.p.A.. The 510(k) number is K153039.
When did MRI Dynamic Analysis Plus receive FDA 510(k) clearance?
MRI Dynamic Analysis Plus received FDA 510(k) clearance on 2016-01-08, under 510(k) number K153039.
Who is the listed applicant for MRI Dynamic Analysis Plus?
FDA 510(k)记录中列出Esaote, S.p.A.为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for MRI Dynamic Analysis Plus?
The FDA product code for MRI Dynamic Analysis Plus 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Esaote, S.p.A.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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