FDA 510(k)

VEA Align；脊柱EOS

K号: K251747 · 2025-08-15

决定日期2025-08-15

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

VEA Align; spineEOS is the device name listed in this FDA 510(k) record. The listed applicant is Eos Imaging. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251747. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VEA Align; spineEOS?

VEA Align; spineEOS is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Eos Imaging. The 510(k) number is K251747.

When did VEA Align; spineEOS receive FDA 510(k) clearance?

VEA Align; spineEOS received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251747.

Who is the listed applicant for VEA Align; spineEOS?

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

What is the FDA product code for VEA Align; spineEOS?

The FDA product code for VEA Align; spineEOS is QIH.

列明Eos Imaging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。

K251078AutoDensity K233920EOSedge K240582VEA Align；脊柱EOS K231917VEA 对齐 K232086脊柱EOS K202394EOSedge

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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。