Swoop® 便携式MR成像® 系统（V2）
K号: K250236 · 2025-05-30
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器械摘要
Swoop® Portable MR Imaging® System (V2) is the device name listed in this FDA 510(k) record. The listed applicant is Hyperfine, Inc.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K250236. 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 Swoop® Portable MR Imaging® System (V2)?
Swoop® Portable MR Imaging® System (V2) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Hyperfine, Inc.. The 510(k) number is K250236.
When did Swoop® Portable MR Imaging® System (V2) receive FDA 510(k) clearance?
Swoop® Portable MR Imaging® System (V2) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250236.
Who is the listed applicant for Swoop® Portable MR Imaging® System (V2)?
FDA 510(k)记录中列出Hyperfine, Inc.为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Swoop® Portable MR Imaging® System (V2)?
The FDA product code for Swoop® Portable MR Imaging® System (V2) 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Hyperfine, 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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