MR DWI/FLAIR測量 V1.0
K 號：K230552 · 2023-04-26
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器材摘要
MR DWI/FLAIR Measurement V1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical. It received FDA 510(k) clearance on 2023-04-26 under 510(k) number K230552. 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 MR DWI/FLAIR Measurement V1.0?
MR DWI/FLAIR Measurement V1.0 is a medical device that received FDA 510(k) clearance on 2023-04-26. The listed applicant is Olea Medical. The 510(k) number is K230552.
When did MR DWI/FLAIR Measurement V1.0 receive FDA 510(k) clearance?
MR DWI/FLAIR Measurement V1.0 received FDA 510(k) clearance on 2023-04-26, under 510(k) number K230552.
Who is the listed applicant for MR DWI/FLAIR Measurement V1.0?
The FDA 510(k) record lists Olea Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MR DWI/FLAIR Measurement V1.0?
The FDA product code for MR DWI/FLAIR Measurement V1.0 is LLZ.
相關臨床試驗
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其他以 Olea Medical 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：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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