APERTO 明亮 MRI 系统
K号: K233629 · 2024-05-10
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器械摘要
APERTO Lucent MRI System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K233629. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
什么是APERTO Lucent MRI系统？
APERTO Lucent MRI System is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233629.
APERTO Lucent MRI系统何时获得FDA 510(k)批准？
APERTO Lucent MRI System received FDA 510(k) clearance on 2024-05-10, under 510(k) number K233629.
谁是APERTO Lucent MRI系统列出的申请人？
The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.
APERTO Lucent MRI系统在FDA的产品代码是什么？
FDA产品代码为APERTO Lucent MRI系统的是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FUJIFILM Healthcare Americas Corporation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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