FDA 510(k)

Axial3D洞察

K 號：K222745 · 2023-07-03

決定日期2023-07-03

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Axial3D Insight is the device name listed in this FDA 510(k) record. The listed applicant is Axial Medical Printing Limited. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K222745. 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 Axial3D Insight?

Axial3D Insight is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Axial Medical Printing Limited. The 510(k) number is K222745.

When did Axial3D Insight receive FDA 510(k) clearance?

Axial3D Insight received FDA 510(k) clearance on 2023-07-03, under 510(k) number K222745.

Who is the listed applicant for Axial3D Insight?

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

What is the FDA product code for Axial3D Insight?

The FDA product code for Axial3D Insight is QIH.

其他以 Axial Medical Printing Limited 為申請人之記錄

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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。

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官方來源

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