數位乳房斷層掃描
PMA 核准號：P160031 · 2023-02-13
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器材摘要
Digital breast tomosynthesis is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2023-02-13. The device is classified under product code OTE. It was reviewed by the RA advisory panel.
常見問題
What is the Digital breast tomosynthesis?
Digital breast tomosynthesis is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Fujifilm Medical Systems U.S.A, Inc..
When did Digital breast tomosynthesis receive FDA 510(k) clearance?
The clearance date for Digital breast tomosynthesis can be found in the official FDA records.
Who is the listed applicant for Digital breast tomosynthesis?
The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Digital breast tomosynthesis?
The FDA product code for Digital breast tomosynthesis is OTE.
相關臨床試驗
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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