FDA 510(k)

Focus 35C探测器，Trimax 35C探测器

K号: K192512 · 2019-10-16

决定日期2019-10-16

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

Focus 35C Detector, Trimax 35C Detector is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2019-10-16 under 510(k) number K192512. 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 Focus 35C Detector, Trimax 35C Detector?

Focus 35C Detector, Trimax 35C Detector is a medical device that received FDA 510(k) clearance on 2019-10-16. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K192512.

When did Focus 35C Detector, Trimax 35C Detector receive FDA 510(k) clearance?

Focus 35C Detector, Trimax 35C Detector received FDA 510(k) clearance on 2019-10-16, under 510(k) number K192512.

Who is the listed applicant for Focus 35C Detector, Trimax 35C Detector?

The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Focus 35C Detector, Trimax 35C Detector?

The FDA product code for Focus 35C Detector, Trimax 35C Detector is MQB.

列明Iray Technology Taicang , 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。

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