FDA 510(k)

约塞米蒂视界 4343W/约塞米蒂视界 3643W

K号: K232058 · 2023-08-03

申请人Careray Digital Medical Technology Co., Ltd.

决定日期2023-08-03

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

YosemiteView 4343W/YosemiteView 3643W is the device name listed in this FDA 510(k) record. The listed applicant is Careray Digital Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K232058. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the YosemiteView 4343W/YosemiteView 3643W?

YosemiteView 4343W/YosemiteView 3643W is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Careray Digital Medical Technology Co., Ltd.. The 510(k) number is K232058.

When did YosemiteView 4343W/YosemiteView 3643W receive FDA 510(k) clearance?

YosemiteView 4343W/YosemiteView 3643W received FDA 510(k) clearance on 2023-08-03, under 510(k) number K232058.

Who is the listed applicant for YosemiteView 4343W/YosemiteView 3643W?

The FDA 510(k) record lists Careray Digital Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YosemiteView 4343W/YosemiteView 3643W?

The FDA product code for YosemiteView 4343W/YosemiteView 3643W is MQB.

列明Careray Digital Medical Technology Co., Ltd.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。

K223687X射线平板探测器（EverestView 4343X）K221549X射线平板探测器（CareView 1800 RF）

官方来源

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