FDA 510(k)

Hi-D Imaging 4TAVR

K号: K241984 · 2025-04-02

决定日期2025-04-02

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Hi-D Imaging 4TAVR is the device name listed in this FDA 510(k) record. The listed applicant is Hi-D Imaging AG. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K241984. 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Hi-D Imaging 4TAVR？

Hi-D Imaging 4TAVR is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Hi-D Imaging AG. The 510(k) number is K241984.

Hi-D Imaging 4TAVR何时获得FDA 510(k)批准？

Hi-D Imaging 4TAVR received FDA 510(k) clearance on 2025-04-02, under 510(k) number K241984.

Hi-D Imaging 4TAVR的列名申请人是谁？

FDA 510(k)记录显示Hi-D Imaging AG为申请人。这本身并不能确立该设备制造商的身份。

Hi-D Imaging 4TAVR的FDA产品代码是什么？

FDA产品代码为Hi-D Imaging 4TAVR的是QIH。

列明Hi-D Imaging AG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。

K261535Hi-D Imaging 4TAVR

官方来源

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