FDA 510(k)

Nexus DRF 数字X射线成像系统

K号: K253103 · 2026-05-29

决定日期2026-05-29

产品代码JAA

咨询委员会RA

决定实质等同

器械摘要

Nexus DRF Digital X-ray Imaging System 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 2026-05-29 under 510(k) number K253103. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nexus DRF Digital X-ray Imaging System?

Nexus DRF Digital X-ray Imaging System is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Varex Imaging Corporation. The 510(k) number is K253103.

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

Nexus DRF Digital X-ray Imaging System received FDA 510(k) clearance on 2026-05-29, under 510(k) number K253103.

Who is the listed applicant for Nexus DRF Digital X-ray Imaging System?

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 DRF Digital X-ray Imaging System?

The FDA product code for Nexus DRF Digital X-ray Imaging System is JAA.

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。

K193238Nexus DR 数字X射线成像系统（带vSharp）K190146Nexus DR 数字X射线成像系统 K183212Nexus DR 数字X射线成像系统（拼接）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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