超音波成像系統（LU700系列）；超音波成像系統（128系列）；超音波成像系統（LX系列）
K 號：K243226 · 2025-05-08
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器材摘要
常見問題
What is the Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)?
Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Leltek, Inc.. The 510(k) number is K243226.
When did Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) receive FDA 510(k) clearance?
Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) received FDA 510(k) clearance on 2025-05-08, under 510(k) number K243226.
Who is the listed applicant for Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)?
The FDA 510(k) record lists Leltek, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)?
The FDA product code for Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) is IYN.
相關臨床試驗
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其他以 Leltek, 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：IYN）
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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