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FDA 510(k)

C Scope Visualization System

K 號：K203526 · 2021-01-12

申請人Cit Ortho
決定日期2021-01-12
產品代碼HRX
諮詢委員會或
決定相當於

器材摘要

C Scope Visualization System is the device name listed in this FDA 510(k) record. The listed applicant is Cit Ortho. It received FDA 510(k) clearance on 2021-01-12 under 510(k) number K203526. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the C Scope Visualization System?

C Scope Visualization System is a medical device that received FDA 510(k) clearance on 2021-01-12. The listed applicant is Cit Ortho. The 510(k) number is K203526.

When did C Scope Visualization System receive FDA 510(k) clearance?

C Scope Visualization System received FDA 510(k) clearance on 2021-01-12, under 510(k) number K203526.

Who is the listed applicant for C Scope Visualization System?

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

What is the FDA product code for C Scope Visualization System?

The FDA product code for C Scope Visualization System is HRX.

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

相關器械（代碼：HRX）

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。

K260203富麗椎體成形術氣球針管Beijing Fule Science & Technology Development Co., Ltd.K254103霍普金斯內視鏡術望遠鏡Karl Storz SE & CO. KGK252790數位ClarusScope系統及數位NeuroPEN系統Clarus Medical, LLCK253523Freedom DS™ 解壓系統Spinal SimplicityK252546Vantage™ 腰椎减压套件Allevion Medical, LLCK253217MiiS Horus 鼻喉鏡 (EJA 100)；MiiS Horus 結腸鏡顯示系統 - 平板 (EDS 500)；MiiS Horus 結腸鏡顯示系統 - 遙控盒 (EVS 700)Medimaging Integrated Solution, Inc (Miis)

官方來源

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