Brainomix 360 e-ASPECTS
K号: K243294 · 2025-02-14
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器械摘要
Brainomix 360 e-ASPECTS is the device name listed in this FDA 510(k) record. The listed applicant is Brainomix Limited. It received FDA 510(k) clearance on 2025-02-14 under 510(k) number K243294. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Brainomix 360 e-ASPECTS?
Brainomix 360 e-ASPECTS is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is Brainomix Limited. The 510(k) number is K243294.
When did Brainomix 360 e-ASPECTS receive FDA 510(k) clearance?
Brainomix 360 e-ASPECTS received FDA 510(k) clearance on 2025-02-14, under 510(k) number K243294.
Who is the listed applicant for Brainomix 360 e-ASPECTS?
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 e-ASPECTS?
The FDA product code for Brainomix 360 e-ASPECTS is POK.
相关临床试验
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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。
相关器械（代码：POK）
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。
K253884Koios DS（3.8）Koios Medical, Inc.K261519Sonio SuspectSonioK254161自动主动脉瓣狭窄软件（AutoAS）GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK251769RevealAI-LungPrecision Medical Ventures, Inc. Dba RevealdxK252294胎儿超声扫描仪（v1.2）BrightheartK250221StrokeSENS ASPECTS软件应用Circle Cardiovascular Imaging, Inc.
官方来源
在 FDA 数据库中查看 →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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