FDA 510(k)

內馬克X 放射性顯影標記

K 號：K191087 · 2019-12-18

決定日期2019-12-18

產品代碼FFX

諮詢委員會GU

決定相當於

器材摘要

IntraMarX Radiopaque Markers 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 2019-12-18 under 510(k) number K191087. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IntraMarX Radiopaque Markers?

IntraMarX Radiopaque Markers is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is Anx Robotica Corp. The 510(k) number is K191087.

When did IntraMarX Radiopaque Markers receive FDA 510(k) clearance?

IntraMarX Radiopaque Markers received FDA 510(k) clearance on 2019-12-18, under 510(k) number K191087.

Who is the listed applicant for IntraMarX Radiopaque Markers?

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 IntraMarX Radiopaque Markers?

The FDA product code for IntraMarX Radiopaque Markers is FFX.

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）K230694NaviCam Xpress 胃系統，NaviCam Xpress 系統 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

相關器械（代碼：FFX）

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。

K252605mcompass 直腸氣球排出針筒 (RMD-003-001)Medspira, LLC K240007太陽能精簡型（G4-1）Laborie Medical Technologies, Corp.K231861Endoflip™ 300 系統Covidien, LLC K223705Endoflip™ 300Covidien, LLC K222000通運-膠囊Medifactia AB K201106IntraMarX 3D 放射性不透明標記Anx Robotica Corp

官方來源

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