Genius AI偵測2.0搭配CC-MLO相關性
K 號：K230096 · 2023-05-23
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器材摘要
Genius AI Detection 2.0 with CC-MLO Correlation is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2023-05-23 under 510(k) number K230096. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Genius AI Detection 2.0 with CC-MLO Correlation?
Genius AI Detection 2.0 with CC-MLO Correlation is a medical device that received FDA 510(k) clearance on 2023-05-23. The listed applicant is Hologic, Inc.. The 510(k) number is K230096.
When did Genius AI Detection 2.0 with CC-MLO Correlation receive FDA 510(k) clearance?
Genius AI Detection 2.0 with CC-MLO Correlation received FDA 510(k) clearance on 2023-05-23, under 510(k) number K230096.
Who is the listed applicant for Genius AI Detection 2.0 with CC-MLO Correlation?
FDA 510(k) 記錄將霍洛基克公司（Hologic, Inc.）列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Genius AI Detection 2.0 with CC-MLO Correlation?
The FDA product code for Genius AI Detection 2.0 with CC-MLO Correlation is QDQ.
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。
其他以 Hologic, Inc. 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。
相關器械（代碼：QDQ）
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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