FDA 510(k)

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)

K号: K161368 · 2016-09-22

决定日期2016-09-22

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) 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 2016-09-22 under 510(k) number K161368. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)?

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K161368.

When did DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) receive FDA 510(k) clearance?

DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) received FDA 510(k) clearance on 2016-09-22, under 510(k) number K161368.

Who is the listed applicant for DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)?

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 DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)?

The FDA product code for DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) is MQB.

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 K170434Enterprise Imaging XERO Viewer 8.1 K161061IMPAX 体积查看 4.0

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