FDA 510(k)

X-MIND 三冠

K 號：K160166 · 2016-11-15

決定日期2016-11-15

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

X-MIND trium 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 2016-11-15 under 510(k) number K160166. 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 trium?

X-MIND trium is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is De Gotzen S.R.L.. The 510(k) number is K160166.

When did X-MIND trium receive FDA 510(k) clearance?

X-MIND trium received FDA 510(k) clearance on 2016-11-15, under 510(k) number K160166.

Who is the listed applicant for X-MIND trium?

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 trium?

The FDA product code for X-MIND trium 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。

K201382X-MIND prime 3D（商標名為Acteon），I-MAX 3D（商標名為Owandy Radiology）K191719X-MIND Trium K192165Acteon Imaging Suite

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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