PowerLook 螢光檢測 V2 軟體
K 號：K182373 · 2018-12-06
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器材摘要
PowerLook Tomo Detection V2 Software is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K182373. 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 PowerLook Tomo Detection V2 Software?
PowerLook Tomo Detection V2 Software is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Icad, Inc.. The 510(k) number is K182373.
When did PowerLook Tomo Detection V2 Software receive FDA 510(k) clearance?
PowerLook Tomo Detection V2 Software received FDA 510(k) clearance on 2018-12-06, under 510(k) number K182373.
Who is the listed applicant for PowerLook Tomo Detection V2 Software?
The FDA 510(k) record lists Icad, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PowerLook Tomo Detection V2 Software?
The FDA product code for PowerLook Tomo Detection V2 Software is QDQ.
相關臨床試驗
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其他以 Icad, 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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