AI-Rad Companion脑部MRI
K号: K253057 · 2026-01-22
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器械摘要
AI-Rad Companion Brain MR is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K253057. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AI-Rad Companion Brain MR?
AI-Rad Companion Brain MR is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K253057.
When did AI-Rad Companion Brain MR receive FDA 510(k) clearance?
AI-Rad Companion Brain MR received FDA 510(k) clearance on 2026-01-22, under 510(k) number K253057.
Who is the listed applicant for AI-Rad Companion Brain MR?
The FDA 510(k) record lists Siemens Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AI-Rad Companion Brain MR?
The FDA product code for AI-Rad Companion Brain MR is QIH.
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Siemens Healthcare GmbH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。
K253264我的消融指南（VC10A）K252548AI-Rad Companion器官实时放疗K253689syngo Dynamics (VA41F)K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseK252608AI-Rad Companion前列腺MRIK250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
相关器械（代码：QIH）
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。
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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