FDA 510(k)

NaviCam Xpress 胃系統，NaviCam Xpress 系統

K 號：K230694 · 2023-04-13

決定日期2023-04-13

產品代碼QKZ

諮詢委員會GU

決定相當於

器材摘要

NaviCam Xpress Stomach System, NaviCam Xpress System is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corp. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K230694. The device is classified under product code QKZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NaviCam Xpress Stomach System, NaviCam Xpress System?

NaviCam Xpress Stomach System, NaviCam Xpress System is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Anx Robotica Corp. The 510(k) number is K230694.

When did NaviCam Xpress Stomach System, NaviCam Xpress System receive FDA 510(k) clearance?

NaviCam Xpress Stomach System, NaviCam Xpress System received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230694.

Who is the listed applicant for NaviCam Xpress Stomach System, NaviCam Xpress System?

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

What is the FDA product code for NaviCam Xpress Stomach System, NaviCam Xpress System?

The FDA product code for NaviCam Xpress Stomach System, NaviCam Xpress System is QKZ.

其他以 Anx Robotica Corp 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。

K241934NaviCam Xpress 胃囊內視鏡系統（NaviCam Xpress 胃系統）搭配 NaviCam 胃囊/繩索（NaviCam Xpress 胃系統搭配 NaviCam 標籤/繩索）K221608NaviCam 胶囊內視鏡系統，搭配 NaviCam 胃膽胶囊及 NaviCam 緊縮線，NaviCam Xpress 胃膽胶囊內視鏡系統（NaviCam Xpress 胃膽系統），搭配 NaviCam 胃膽胶囊及 NaviCam 緊縮線 K203192NaviCam Xpress 胃部系統 K201106IntraMarX 3D 放射性不透明標記 K191087內馬克X 放射性顯影標記

相關器械（代碼：QKZ）

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。

K241934NaviCam Xpress 胃囊內視鏡系統（NaviCam Xpress 胃系統）搭配 NaviCam 胃囊/繩索（NaviCam Xpress 胃系統搭配 NaviCam 標籤/繩索）Anx Robotica Corp K231960NaviCam Xpress 胃囊內視鏡系統（NaviCam Xpress 胃系統）搭配 NaviCam 擋桿及 NaviCam 緊繫器Anx Robotica Corporation K221608NaviCam 胶囊內視鏡系統，搭配 NaviCam 胃膽胶囊及 NaviCam 緊縮線，NaviCam Xpress 胃膽胶囊內視鏡系統（NaviCam Xpress 胃膽系統），搭配 NaviCam 胃膽胶囊及 NaviCam 緊縮線Anx Robotica Corp K203192NaviCam Xpress 胃部系統Anx Robotica Corp

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