ECHELON 椭圆形 V 5.1 MRI 系统
K号: K153547 · 2016-03-31
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器械摘要
ECHELON Oval V 5.1 MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K153547. 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 ECHELON Oval V 5.1 MRI System?
ECHELON Oval V 5.1 MRI System is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K153547.
When did ECHELON Oval V 5.1 MRI System receive FDA 510(k) clearance?
ECHELON Oval V 5.1 MRI System received FDA 510(k) clearance on 2016-03-31, under 510(k) number K153547.
Who is the listed applicant for ECHELON Oval V 5.1 MRI System?
The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ECHELON Oval V 5.1 MRI System?
The FDA product code for ECHELON Oval V 5.1 MRI System 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Hitachi Medical Systems America, Inc.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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