FDA 510(k)

3mensio 工作站

K 號：K250330 · 2025-11-03

決定日期2025-11-03

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

3mensio Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2025-11-03 under 510(k) number K250330. 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 3mensio Workstation?

3mensio Workstation is a medical device that received FDA 510(k) clearance on 2025-11-03. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K250330.

When did 3mensio Workstation receive FDA 510(k) clearance?

3mensio Workstation received FDA 510(k) clearance on 2025-11-03, under 510(k) number K250330.

Who is the listed applicant for 3mensio Workstation?

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

What is the FDA product code for 3mensio Workstation?

The FDA product code for 3mensio Workstation is QIH.

其他以 Pie Medical Imaging BV 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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