FDA 510(k)

VEA Align；脊椎EOS

K 號：K251747 · 2025-08-15

決定日期2025-08-15

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Eos Imaging 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：QIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家Visiana K261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care Diagnostics K261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

官方來源

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