FDA 510(k)

IntraMarX 3D 放射性不透明標記

K 號：K201106 · 2020-05-21

決定日期2020-05-21

產品代碼FFX

諮詢委員會GU

決定相當於

器材摘要

IntraMarX 3D Radiopaque Marker 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 2020-05-21 under 510(k) number K201106. 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 3D Radiopaque Marker?

IntraMarX 3D Radiopaque Marker is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Anx Robotica Corp. The 510(k) number is K201106.

When did IntraMarX 3D Radiopaque Marker receive FDA 510(k) clearance?

IntraMarX 3D Radiopaque Marker received FDA 510(k) clearance on 2020-05-21, under 510(k) number K201106.

Who is the listed applicant for IntraMarX 3D Radiopaque Marker?

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 3D Radiopaque Marker?

The FDA product code for IntraMarX 3D Radiopaque Marker 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。

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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 K191087內馬克X 放射性顯影標記Anx Robotica Corp

官方來源

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