FDA 510(k)

x-mind dc（商標名為Acteon），Owandy-RX DC（商標名為OwandyRadiology）

K 號：K231055 · 2023-12-28

決定日期2023-12-28

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) is the device name listed in this FDA 510(k) record. The listed applicant is De Götzen S.R.L.. It received FDA 510(k) clearance on 2023-12-28 under 510(k) number K231055. 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 x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)?

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) is a medical device that received FDA 510(k) clearance on 2023-12-28. The listed applicant is De Götzen S.R.L.. The 510(k) number is K231055.

When did x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) receive FDA 510(k) clearance?

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) received FDA 510(k) clearance on 2023-12-28, under 510(k) number K231055.

Who is the listed applicant for x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)?

The FDA 510(k) record lists De Götzen S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)?

The FDA product code for x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) is EHD.

其他以 De Götzen S.R.L. 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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