視覺乳房密度
K 號：K201411 · 2021-01-29
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器材摘要
Visage Breast Density is the device name listed in this FDA 510(k) record. The listed applicant is Visage Imaging GmbH. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201411. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Visage Breast Density?
Visage Breast Density is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Visage Imaging GmbH. The 510(k) number is K201411.
When did Visage Breast Density receive FDA 510(k) clearance?
Visage Breast Density received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201411.
Who is the listed applicant for Visage Breast Density?
The FDA 510(k) record lists Visage Imaging GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Visage Breast Density?
The FDA product code for Visage Breast Density is QIH.
相關臨床試驗
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相關器械（代碼：QIH）
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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