VEGA輔助影像導引系統 (VF-VIS-002)
K 號：K260885 · 2026-06-15
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器材摘要
VERAFEYE Imaging and Guidance System (VF-VIS-002) is the device name listed in this FDA 510(k) record. The listed applicant is Luma Vision Limited. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260885. FDA Decision: Substantially Equivalent.
常見問題
What is the VERAFEYE Imaging and Guidance System (VF-VIS-002)?
VERAFEYE Imaging and Guidance System (VF-VIS-002) is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Luma Vision Limited. The 510(k) number is K260885.
When did VERAFEYE Imaging and Guidance System (VF-VIS-002) receive FDA 510(k) clearance?
VERAFEYE Imaging and Guidance System (VF-VIS-002) received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260885.
Who is the listed applicant for VERAFEYE Imaging and Guidance System (VF-VIS-002)?
FDA 510(k) 記錄將 Luma Vision Limited 列為申請人。這並不單獨確立設備製造商。
相關臨床試驗
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。
其他以 Luma Vision Limited 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。
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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