FDA 510(k)

VERAFEYE 系統 VERAFEYE 許可成像導管與 VERAFEYE 許可成像系統

K 號：K242893 · 2025-03-24

決定日期2025-03-24

產品代碼OBJ

諮詢委員會履歷

決定相當於

器材摘要

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System 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 2025-03-24 under 510(k) number K242893. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Luma Vision Limited. The 510(k) number is K242893.

When did VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System receive FDA 510(k) clearance?

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System received FDA 510(k) clearance on 2025-03-24, under 510(k) number K242893.

Who is the listed applicant for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

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。

What is the FDA product code for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

The FDA product code for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System is OBJ.

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。

K261849VEGAFAYE影像導管（VF-VIC-002）K260885VEGA輔助影像導引系統 (VF-VIS-002)

相關器械（代碼：OBJ）

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

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