FDA 510(k)

牙科CT掃描儀 AXR

K 號：K223816 · 2023-04-07

申請人Alliage S/A Industrias Medico Odontológica

決定日期2023-04-07

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

Dental CT Scanner AXR is the device name listed in this FDA 510(k) record. The listed applicant is Alliage S/A Industrias Medico Odontológica. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K223816. 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 Dental CT Scanner AXR?

Dental CT Scanner AXR is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Alliage S/A Industrias Medico Odontológica. The 510(k) number is K223816.

When did Dental CT Scanner AXR receive FDA 510(k) clearance?

Dental CT Scanner AXR received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223816.

Who is the listed applicant for Dental CT Scanner AXR?

The FDA 510(k) record lists Alliage S/A Industrias Medico Odontológica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental CT Scanner AXR?

The FDA product code for Dental CT Scanner AXR is OAS.

其他以 Alliage S/A Industrias Medico Odontológica 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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