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FDA 510(k)

FloNavi內視鏡式荧光成像系統

K 號：K221861 · 2023-02-18

申請人Guangdong Optomedic Technologies, Inc.
決定日期2023-02-18
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

FloNavi Endoscopic Fluorescence Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-18 under 510(k) number K221861. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FloNavi Endoscopic Fluorescence Imaging System?

FloNavi Endoscopic Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2023-02-18. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K221861.

When did FloNavi Endoscopic Fluorescence Imaging System receive FDA 510(k) clearance?

FloNavi Endoscopic Fluorescence Imaging System received FDA 510(k) clearance on 2023-02-18, under 510(k) number K221861.

Who is the listed applicant for FloNavi Endoscopic Fluorescence Imaging System?

The FDA 510(k) record lists Guangdong Optomedic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FloNavi Endoscopic Fluorescence Imaging System?

The FDA product code for FloNavi Endoscopic Fluorescence Imaging System is GCJ.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Guangdong Optomedic Technologies, 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。

K252318充氣器（OPTO-IFL1000）K2526973D腹腔镜K242513FloNavi內視鏡式荧光成像系統（OPTO-CAM214K、OPTO-CHD214KE、OPTOCHD214KH、OPTO-LED214K）K241530星光影像系統K231342充氣器（OPTO-IFL1000）K230407FloNavi 開放式場域荧光影像系統

查看所有 9 項裝置 →

相關器械（代碼：GCJ）

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。

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE選擇系統Karl Storz SE & CO. KGK260972OEV-271MUH LCD 螢幕；OEV-321MUH LCD 螢幕；OEV-431MUH LCD 螢幕Sony CorporationK261139VereSee (VER150、VER200、VER151、VER201、VER200C 及 VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™（EZ Close Port Site Closing Device、EZ Close MAX Port Site Closing Device、EZ Close II Port Site Closing Device）Medical ImpactK261614LED LCD 螢幕 (OEV-271H)Lg Electronics.Inc

官方來源

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