FDA 510(k)

Orthoscan TAU Mini C-臂

K 號：K250587 · 2025-07-02

決定日期2025-07-02

產品代碼OXO

諮詢委員會RA

決定相當於

器材摘要

Orthoscan TAU Mini C-Arm is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm-Orthoscan, Inc.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250587. 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 Orthoscan TAU Mini C-Arm?

Orthoscan TAU Mini C-Arm is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Ziehm-Orthoscan, Inc.. The 510(k) number is K250587.

When did Orthoscan TAU Mini C-Arm receive FDA 510(k) clearance?

Orthoscan TAU Mini C-Arm received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250587.

Who is the listed applicant for Orthoscan TAU Mini C-Arm?

The FDA 510(k) record lists Ziehm-Orthoscan, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orthoscan TAU Mini C-Arm?

The FDA product code for Orthoscan TAU Mini C-Arm is OXO.

其他以 Ziehm-Orthoscan, Inc. 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。

K252579Orthoscan TAU MVP Mini C-Arm 系統 K243452Orthoscan VERSA Mini C-臂

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。

K253296數位C-ARM搭配3DAllengers Medical Systems Limited K252579Orthoscan TAU MVP Mini C-Arm 系統Ziehm-Orthoscan, Inc.K253269OEC One 液體流體動力學設備Ge Hualun Medical Systems Co. , Ltd.K251004雙模式移動C臂（Geelin500A，Geelin500M）Hefei Chimed Intelligent Machine Co., Ltd.K243452Orthoscan VERSA Mini C-臂Ziehm-Orthoscan, Inc.K240828OEC 一 ASDGe Hualun Medical Systems Co. , Ltd.

官方來源

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