FDA 510(k)

PACS CORE/ENCORE

K号: K161518 · 2016-08-17

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

决定日期2016-08-17

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

PACS CORE/ENCORE 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 2016-08-17 under 510(k) number K161518. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PACS CORE/ENCORE?

PACS CORE/ENCORE is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. The 510(k) number is K161518.

When did PACS CORE/ENCORE receive FDA 510(k) clearance?

PACS CORE/ENCORE received FDA 510(k) clearance on 2016-08-17, under 510(k) number K161518.

Who is the listed applicant for PACS CORE/ENCORE?

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 PACS CORE/ENCORE?

The FDA product code for PACS CORE/ENCORE is LLZ.

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 K182134ARiX RAD X光系统

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