AVIEW肺結節計算機輔助診斷
K 號：K221592 · 2023-02-24
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器材摘要
AVIEW Lung Nodule CAD is the device name listed in this FDA 510(k) record. The listed applicant is Coreline Soft Co., Ltd.. It received FDA 510(k) clearance on 2023-02-24 under 510(k) number K221592. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AVIEW Lung Nodule CAD?
AVIEW Lung Nodule CAD is a medical device that received FDA 510(k) clearance on 2023-02-24. The listed applicant is Coreline Soft Co., Ltd.. The 510(k) number is K221592.
When did AVIEW Lung Nodule CAD receive FDA 510(k) clearance?
AVIEW Lung Nodule CAD received FDA 510(k) clearance on 2023-02-24, under 510(k) number K221592.
Who is the listed applicant for AVIEW Lung Nodule CAD?
The FDA 510(k) record lists Coreline Soft Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AVIEW Lung Nodule CAD?
The FDA product code for AVIEW Lung Nodule CAD is OEB.
相關臨床試驗
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其他以 Coreline Soft Co., Ltd. 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：OEB）
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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