FDA 510(k)

Brainomix 360 三级诊断 LVO

K号: K231837 · 2023-09-28

决定日期2023-09-28

产品代码QAS

咨询委员会RA

决定实质等同

器械摘要

Brainomix 360 Triage LVO is the device name listed in this FDA 510(k) record. The listed applicant is Brainomix Limited. It received FDA 510(k) clearance on 2023-09-28 under 510(k) number K231837. 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 Brainomix 360 Triage LVO?

Brainomix 360 Triage LVO is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Brainomix Limited. The 510(k) number is K231837.

When did Brainomix 360 Triage LVO receive FDA 510(k) clearance?

Brainomix 360 Triage LVO received FDA 510(k) clearance on 2023-09-28, under 510(k) number K231837.

Who is the listed applicant for Brainomix 360 Triage LVO?

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

What is the FDA product code for Brainomix 360 Triage LVO?

The FDA product code for Brainomix 360 Triage LVO is QAS.

列明Brainomix Limited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。

K260406Brainomix 360 Hyperdensity K251983Brainomix 360 三级诊断中风 K242411Brainomix 360 e-Lung K243294Brainomix 360 e-ASPECTS K242123Brainomix 360 e-CTA K233875Brainomix 360 e-Lung

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官方来源

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