FDA 510(k)

ARiX RAD X光系统

K号: K182134 · 2018-11-26

申请人Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.

决定日期2018-11-26

产品代码KPR

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K193637MRH ALFA X射线成像系统，MRH II X射线成像系统，MRH IIE X射线成像系统 K161518PACS CORE/ENCORE

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