FDA 510(k)

Enterprise Imaging XERO Viewer 8.1

K号: K170434 · 2017-07-03

决定日期2017-07-03

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Enterprise Imaging XERO Viewer 8.1 is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2017-07-03 under 510(k) number K170434. 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 Enterprise Imaging XERO Viewer 8.1?

Enterprise Imaging XERO Viewer 8.1 is a medical device that received FDA 510(k) clearance on 2017-07-03. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K170434.

When did Enterprise Imaging XERO Viewer 8.1 receive FDA 510(k) clearance?

Enterprise Imaging XERO Viewer 8.1 received FDA 510(k) clearance on 2017-07-03, under 510(k) number K170434.

Who is the listed applicant for Enterprise Imaging XERO Viewer 8.1?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enterprise Imaging XERO Viewer 8.1?

The FDA product code for Enterprise Imaging XERO Viewer 8.1 is LLZ.

列明Agfa Healthcare N.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。

K252199AGFA HealthCare企业成像 K180589DR 800 配备 MUSICA 动态系统 K172784DX-D Imaging Package K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)K161061IMPAX 体积查看 4.0

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