FDA 510(k)

Clarius 超声波扫描仪

K号: K232704 · 2023-10-05

决定日期2023-10-05

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Clarius Ultrasound Scanner 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 2023-10-05 under 510(k) number K232704. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Clarius Ultrasound Scanner?

Clarius Ultrasound Scanner is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Clarius Mobile Health Corp.. The 510(k) number is K232704.

When did Clarius Ultrasound Scanner receive FDA 510(k) clearance?

Clarius Ultrasound Scanner received FDA 510(k) clearance on 2023-10-05, under 510(k) number K232704.

Who is the listed applicant for Clarius Ultrasound Scanner?

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 Ultrasound Scanner?

The FDA product code for Clarius Ultrasound Scanner is IYN.

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 K250226Clarius 正中神经 AI K243853Clarius 前列腺 AI K233955Clarius 骨盆 AI K232257Clarius 膀胱 AI K222406Clarius AI

查看所有 12 个设备 →

相关器械（代码：IYN）

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

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。