歐米茄AI影像檢視器
K 號：K222476 · 2022-11-17
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器材摘要
OmegaAI Image Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Ramsoft, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K222476. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OmegaAI Image Viewer?
OmegaAI Image Viewer is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Ramsoft, Inc.. The 510(k) number is K222476.
When did OmegaAI Image Viewer receive FDA 510(k) clearance?
OmegaAI Image Viewer received FDA 510(k) clearance on 2022-11-17, under 510(k) number K222476.
Who is the listed applicant for OmegaAI Image Viewer?
The FDA 510(k) record lists Ramsoft, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OmegaAI Image Viewer?
The FDA product code for OmegaAI Image Viewer is LLZ.
相關臨床試驗
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相關器械（代碼：LLZ）
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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