FDA 510(k)

Rapid CTA 360

K号: K251151 · 2025-07-16

决定日期2025-07-16

产品代码QAS

咨询委员会RA

决定实质等同

器械摘要

Rapid CTA 360 is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview. It received FDA 510(k) clearance on 2025-07-16 under 510(k) number K251151. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rapid CTA 360?

Rapid CTA 360 is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Ischemaview. The 510(k) number is K251151.

When did Rapid CTA 360 receive FDA 510(k) clearance?

Rapid CTA 360 received FDA 510(k) clearance on 2025-07-16, under 510(k) number K251151.

Who is the listed applicant for Rapid CTA 360?

The FDA 510(k) record lists Ischemaview as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid CTA 360?

The FDA product code for Rapid CTA 360 is QAS.

列明Ischemaview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。

K261085快速血管闭塞（快速VO）

官方来源

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