FDA 510(k)

X-MIND prime 3D（商標名為Acteon），I-MAX 3D（商標名為Owandy Radiology）

K 號：K201382 · 2020-11-18

決定日期2020-11-18

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is the device name listed in this FDA 510(k) record. The listed applicant is De Gotzen S.R.L.. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K201382. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)?

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is De Gotzen S.R.L.. The 510(k) number is K201382.

When did X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) receive FDA 510(k) clearance?

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) received FDA 510(k) clearance on 2020-11-18, under 510(k) number K201382.

Who is the listed applicant for X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)?

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

What is the FDA product code for X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)?

The FDA product code for X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is OAS.

其他以 De Gotzen 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：OAS）

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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