FDA 510(k)

設備名稱醫療設備規範文本請參考以下翻譯：設備名稱醫療設備規範文本說明：DL 注意：公司名稱、產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址等均保持原樣。

K 號：K241350 · 2025-01-03

申請人Ge Medical Systems Israel, Functional Imaging

決定日期2025-01-03

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Clarify DL is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Israel, Functional Imaging. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K241350. 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 Clarify DL?

Clarify DL is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Ge Medical Systems Israel, Functional Imaging. The 510(k) number is K241350.

When did Clarify DL receive FDA 510(k) clearance?

Clarify DL received FDA 510(k) clearance on 2025-01-03, under 510(k) number K241350.

Who is the listed applicant for Clarify DL?

The FDA 510(k) record lists Ge Medical Systems Israel, Functional Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clarify DL?

The FDA product code for Clarify DL is LLZ.

其他以 Ge Medical Systems Israel, Functional Imaging 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。

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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。

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官方來源

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