FDA 510(k)

Clarius 正中神经 AI

K号: K250226 · 2025-05-08

决定日期2025-05-08

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Clarius Median Nerve AI is the device name listed in this FDA 510(k) record. The listed applicant is Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2025-05-08 under 510(k) number K250226. 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 Clarius Median Nerve AI?

Clarius Median Nerve AI is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Clarius Mobile Health Corp.. The 510(k) number is K250226.

When did Clarius Median Nerve AI receive FDA 510(k) clearance?

Clarius Median Nerve AI received FDA 510(k) clearance on 2025-05-08, under 510(k) number K250226.

Who is the listed applicant for Clarius Median Nerve AI?

The FDA 510(k) record lists Clarius Mobile Health Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clarius Median Nerve AI?

The FDA product code for Clarius Median Nerve AI is QIH.

列明Clarius Mobile Health Corp.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。

K253593Clarius 射血分数 AI K243853Clarius 前列腺 AI K233955Clarius 骨盆 AI K232257Clarius 膀胱 AI K232704Clarius 超声波扫描仪 K222406Clarius AI

查看所有 12 个设备 →

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。