FDA 510(k)

數位C-ARM搭配3D

K 號：K253296 · 2026-06-05

決定日期2026-06-05

產品代碼OXO

諮詢委員會RA

決定相當於

器材摘要

Digital C-ARM with 3D is the device name listed in this FDA 510(k) record. The listed applicant is Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K253296. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Digital C-ARM with 3D?

Digital C-ARM with 3D is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Allengers Medical Systems Limited. The 510(k) number is K253296.

When did Digital C-ARM with 3D receive FDA 510(k) clearance?

Digital C-ARM with 3D received FDA 510(k) clearance on 2026-06-05, under 510(k) number K253296.

Who is the listed applicant for Digital C-ARM with 3D?

The FDA 510(k) record lists Allengers Medical Systems Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital C-ARM with 3D?

The FDA product code for Digital C-ARM with 3D is OXO.

其他以 Allengers Medical Systems Limited 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：OXO）

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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官方來源

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