Aorta-CAD
K 號：K213353 · 2022-09-20
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器材摘要
Aorta-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 2022-09-20 under 510(k) number K213353. 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 Aorta-CAD?
Aorta-CAD is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Imagen Technologies, Inc.. The 510(k) number is K213353.
When did Aorta-CAD receive FDA 510(k) clearance?
Aorta-CAD received FDA 510(k) clearance on 2022-09-20, under 510(k) number K213353.
Who is the listed applicant for Aorta-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 Aorta-CAD?
The FDA product code for Aorta-CAD is MYN.
相關臨床試驗
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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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