FDA 510(k)

Brainomix 360 三级诊断中风

K号: K251983 · 2025-08-26

决定日期2025-08-26

产品代码QAS

咨询委员会RA

决定实质等同

器械摘要

Brainomix 360 Triage Stroke is the device name listed in this FDA 510(k) record. The listed applicant is Brainomix Limited. It received FDA 510(k) clearance on 2025-08-26 under 510(k) number K251983. 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 Stroke?

Brainomix 360 Triage Stroke is a medical device that received FDA 510(k) clearance on 2025-08-26. The listed applicant is Brainomix Limited. The 510(k) number is K251983.

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

Brainomix 360 Triage Stroke received FDA 510(k) clearance on 2025-08-26, under 510(k) number K251983.

Who is the listed applicant for Brainomix 360 Triage Stroke?

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 Stroke?

The FDA product code for Brainomix 360 Triage Stroke 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 K242411Brainomix 360 e-Lung K243294Brainomix 360 e-ASPECTS K242123Brainomix 360 e-CTA K233875Brainomix 360 e-Lung K232496Brainomix 360 三级诊断中风

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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。