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FDA 510(k)

qXR-CTR

K号: K231149 · 2023-09-22

决定日期2023-09-22
产品代码QIH
咨询委员会RA
决定实质等同

器械摘要

qXR-CTR is the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231149. 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 qXR-CTR?

qXR-CTR is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Qure.Ai Technologies. The 510(k) number is K231149.

When did qXR-CTR receive FDA 510(k) clearance?

qXR-CTR received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231149.

Who is the listed applicant for qXR-CTR?

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

What is the FDA product code for qXR-CTR?

The FDA product code for qXR-CTR is QIH.

列明Qure.Ai Technologies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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相关器械(代码:QIH)

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。

官方来源

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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。

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