FDA 510(k)

Synapse 3D 基礎工具（V7.0）

K 號：K243762 · 2025-05-21

決定日期2025-05-21

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Synapse 3D Base Tools (V7.0) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K243762. 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 Synapse 3D Base Tools (V7.0)?

Synapse 3D Base Tools (V7.0) is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Fujifilm Corporation. The 510(k) number is K243762.

When did Synapse 3D Base Tools (V7.0) receive FDA 510(k) clearance?

Synapse 3D Base Tools (V7.0) received FDA 510(k) clearance on 2025-05-21, under 510(k) number K243762.

Who is the listed applicant for Synapse 3D Base Tools (V7.0)?

FDA 510(k) 記錄中將富士通公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Synapse 3D Base Tools (V7.0)?

The FDA product code for Synapse 3D Base Tools (V7.0) is QIH.

其他以 Fujifilm Corporation 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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