FDA 510(k)

SwiftMR

K号: K253775 · 2026-03-26

决定日期2026-03-26

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

SwiftMR is the device name listed in this FDA 510(k) record. The listed applicant is Airs Medical, Inc.. It received FDA 510(k) clearance on 2026-03-26 under 510(k) number K253775. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是SwiftMR？

SwiftMR is a medical device that received FDA 510(k) clearance on 2026-03-26. The listed applicant is Airs Medical, Inc.. The 510(k) number is K253775.

SwiftMR何时获得FDA 510(k)批准？

SwiftMR received FDA 510(k) clearance on 2026-03-26, under 510(k) number K253775.

SwiftMR的列名申请人是谁？

FDA 510(k)记录中列出Airs Medical, Inc.为申请人。这本身并不能确立该设备制造商的身份。

SwiftMR的FDA产品代码是什么？

SwiftMR的FDA产品代码为QIH。

列明Airs Medical, 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。

K261349SwiftMR K251483SwiftSight-Brain K230854SwiftMR K220416SwiftMR K210999SwiftMR

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。