FDA 510(k)

Nexus DR 数字X射线成像系统（拼接）

K号: K183212 · 2018-12-07

决定日期2018-12-07

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

Nexus DR Digital X-ray Imaging System with stitching is the device name listed in this FDA 510(k) record. The listed applicant is Varex Imaging Corporation. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K183212. 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 Nexus DR Digital X-ray Imaging System with stitching?

Nexus DR Digital X-ray Imaging System with stitching is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Varex Imaging Corporation. The 510(k) number is K183212.

When did Nexus DR Digital X-ray Imaging System with stitching receive FDA 510(k) clearance?

Nexus DR Digital X-ray Imaging System with stitching received FDA 510(k) clearance on 2018-12-07, under 510(k) number K183212.

Who is the listed applicant for Nexus DR Digital X-ray Imaging System with stitching?

The FDA 510(k) record lists Varex Imaging Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexus DR Digital X-ray Imaging System with stitching?

The FDA product code for Nexus DR Digital X-ray Imaging System with stitching is MQB.

列明Varex Imaging Corporation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。

K253103Nexus DRF 数字X射线成像系统 K193238Nexus DR 数字X射线成像系统（带vSharp）K190146Nexus DR 数字X射线成像系统 K181526XRpad2 4343 HWC-M 平板探测器 K172951Nexus DR 数字X射线成像系统（带PaxScan 4343RC和PaxScan 4343Rv3）K171138Nexus DR 数字X射线成像系统

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。