FDA 510(k)

ARiX RAD射線學系統

K 號：K182134 · 2018-11-26

申請人Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

決定日期2018-11-26

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

ARiX RAD Radiographic System is the device name listed in this FDA 510(k) record. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K182134. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARiX RAD Radiographic System?

ARiX RAD Radiographic System is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The 510(k) number is K182134.

When did ARiX RAD Radiographic System receive FDA 510(k) clearance?

ARiX RAD Radiographic System received FDA 510(k) clearance on 2018-11-26, under 510(k) number K182134.

Who is the listed applicant for ARiX RAD Radiographic System?

The FDA 510(k) record lists Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARiX RAD Radiographic System?

The FDA product code for ARiX RAD Radiographic System is KPR.

其他以 Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. 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。

K193637MRH ALFA 放射學系統，MRH II 放射學系統，MRH IIE 放射學系統 K161518PACS核心/ENCORE

相關器械（代碼：KPR）

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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