肺-CAD
K 號：K223811 · 2023-09-13
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器材摘要
Lung-CAD is the device name listed in this FDA 510(k) record. The listed applicant is Imagen Technologies, Inc.. It received FDA 510(k) clearance on 2023-09-13 under 510(k) number K223811. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Lung-CAD?
Lung-CAD is a medical device that received FDA 510(k) clearance on 2023-09-13. The listed applicant is Imagen Technologies, Inc.. The 510(k) number is K223811.
When did Lung-CAD receive FDA 510(k) clearance?
Lung-CAD received FDA 510(k) clearance on 2023-09-13, under 510(k) number K223811.
Who is the listed applicant for Lung-CAD?
The FDA 510(k) record lists Imagen Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lung-CAD?
The FDA product code for Lung-CAD is MYN.
其他以 Imagen Technologies, 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：MYN）
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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