FDA 510(k)

InferRead CT Stroke.AI

K号: K211179 · 2021-08-12

申请人Infervision Medical Technology Co., Ltd.

决定日期2021-08-12

产品代码QAS

咨询委员会RA

决定实质等同

器械摘要

InferRead CT Stroke.AI is the device name listed in this FDA 510(k) record. The listed applicant is Infervision Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-12 under 510(k) number K211179. 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 InferRead CT Stroke.AI?

InferRead CT Stroke.AI is a medical device that received FDA 510(k) clearance on 2021-08-12. The listed applicant is Infervision Medical Technology Co., Ltd.. The 510(k) number is K211179.

When did InferRead CT Stroke.AI receive FDA 510(k) clearance?

InferRead CT Stroke.AI received FDA 510(k) clearance on 2021-08-12, under 510(k) number K211179.

Who is the listed applicant for InferRead CT Stroke.AI?

The FDA 510(k) record lists Infervision Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InferRead CT Stroke.AI?

The FDA product code for InferRead CT Stroke.AI is QAS.

列明Infervision Medical Technology Co., Ltd.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。

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官方来源

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