FDA 510(k)

攜帶式X光系統（型號：MiniX-V，Mini X-S）

K 號：K181891 · 2018-08-10

決定日期2018-08-10

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Digimed Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：EHD）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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