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FDA 510(k)

1688 4K 鏡頭系統，具有先進影像技術

K 號：K222130 · 2022-08-19

申請人Stryker
決定日期2022-08-19
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

1688 4K Camera System with Advanced Imaging Modality is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K222130. 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 1688 4K Camera System with Advanced Imaging Modality?

1688 4K Camera System with Advanced Imaging Modality is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Stryker. The 510(k) number is K222130.

When did 1688 4K Camera System with Advanced Imaging Modality receive FDA 510(k) clearance?

1688 4K Camera System with Advanced Imaging Modality received FDA 510(k) clearance on 2022-08-19, under 510(k) number K222130.

Who is the listed applicant for 1688 4K Camera System with Advanced Imaging Modality?

The FDA 510(k) record lists Stryker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1688 4K Camera System with Advanced Imaging Modality?

The FDA product code for 1688 4K Camera System with Advanced Imaging Modality 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 Stryker 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。

K2318541788 4K 相機系統配先進成像技術；L12 LED 光源配 AIMK230416Triathlon® 鍵節膝關節系統；Triathlon® 修復插片 X3®K230754L12 LED光源配AIMK2306051788 4K 相機系統配先進成像技術K2302161688 4K 鏡頭控制單元，具有先進影像技術 (1688010000)K220731Insignia 髋關節頭，Restoration 模組化 115mm 間接端頭

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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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