貝拉倫2D (VDMS-1000S)
K 號：K254092 · 2026-05-28
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器材摘要
Bellalun 2D (VDMS-1000S) is the device name listed in this FDA 510(k) record. The listed applicant is Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K254092. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bellalun 2D (VDMS-1000S)?
Bellalun 2D (VDMS-1000S) is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K254092.
When did Bellalun 2D (VDMS-1000S) receive FDA 510(k) clearance?
Bellalun 2D (VDMS-1000S) received FDA 510(k) clearance on 2026-05-28, under 510(k) number K254092.
Who is the listed applicant for Bellalun 2D (VDMS-1000S)?
The FDA 510(k) record lists Vieworks Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bellalun 2D (VDMS-1000S)?
The FDA product code for Bellalun 2D (VDMS-1000S) is MUE.
相關臨床試驗
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其他以 Vieworks 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：MUE）
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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