VinDr-Mammo 医療設備規範文本翻譯： VinDr-Mammo 医療設備規範文本
K 號：K233108 · 2024-05-23
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器材摘要
VinDr-Mammo is the device name listed in this FDA 510(k) record. The listed applicant is Vinbigdata Joint Stock Company. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K233108. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VinDr-Mammo?
VinDr-Mammo is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Vinbigdata Joint Stock Company. The 510(k) number is K233108.
When did VinDr-Mammo receive FDA 510(k) clearance?
VinDr-Mammo received FDA 510(k) clearance on 2024-05-23, under 510(k) number K233108.
Who is the listed applicant for VinDr-Mammo?
The FDA 510(k) record lists Vinbigdata Joint Stock Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VinDr-Mammo?
The FDA product code for VinDr-Mammo is QFM.
相關臨床試驗
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相關器械（代碼：QFM）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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