FDA 510(k)

Vitrea CT经导管主动脉瓣置换术（TAVR）规划

K号: K260324 · 2026-05-22

决定日期2026-05-22

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Informatics, Inc.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K260324. 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 Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning?

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Canon Medical Informatics, Inc.. The 510(k) number is K260324.

When did Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning receive FDA 510(k) clearance?

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning received FDA 510(k) clearance on 2026-05-22, under 510(k) number K260324.

Who is the listed applicant for Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning?

The FDA 510(k) record lists Canon Medical Informatics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning?

The FDA product code for Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is QIH.

列明Canon Medical Informatics, 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。

K252217CT VScore+K243240维特瑞亚CT VScore K223261开放肋 K222662维特瑞亚CT心脏分析

官方来源

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