FDA 510(k)

便携式X射线系统（型号：MiniX-V，Mini X-S）

K号: K181891 · 2018-08-10

决定日期2018-08-10

产品代码EHD

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决定实质等同

器械摘要

Portable X-ray System (Model: MiniX-V, Mini X-S) is the device name listed in this FDA 510(k) record. The listed applicant is Digimed Co., Ltd.. It received FDA 510(k) clearance on 2018-08-10 under 510(k) number K181891. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Portable X-ray System (Model: MiniX-V, Mini X-S)?

Portable X-ray System (Model: MiniX-V, Mini X-S) is a medical device that received FDA 510(k) clearance on 2018-08-10. The listed applicant is Digimed Co., Ltd.. The 510(k) number is K181891.

When did Portable X-ray System (Model: MiniX-V, Mini X-S) receive FDA 510(k) clearance?

Portable X-ray System (Model: MiniX-V, Mini X-S) received FDA 510(k) clearance on 2018-08-10, under 510(k) number K181891.

Who is the listed applicant for Portable X-ray System (Model: MiniX-V, Mini X-S)?

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

What is the FDA product code for Portable X-ray System (Model: MiniX-V, Mini X-S)?

The FDA product code for Portable X-ray System (Model: MiniX-V, Mini X-S) is EHD.

列明Digimed 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。

K221587DHX-70H，XTG-70H K220579Hybrid C70 K220574混合S70

官方来源

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