FDA 510(k)

雙模式移動C臂（Geelin500A，Geelin500M）

K 號：K251004 · 2025-11-06

申請人Hefei Chimed Intelligent Machine Co., Ltd.

決定日期2025-11-06

產品代碼OXO

諮詢委員會RA

決定相當於

器材摘要

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) is the device name listed in this FDA 510(k) record. The listed applicant is Hefei Chimed Intelligent Machine Co., Ltd.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K251004. 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 Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)?

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Hefei Chimed Intelligent Machine Co., Ltd.. The 510(k) number is K251004.

When did Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) receive FDA 510(k) clearance?

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K251004.

Who is the listed applicant for Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)?

The FDA 510(k) record lists Hefei Chimed Intelligent Machine Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)?

The FDA product code for Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) is OXO.

相關器械（代碼：OXO）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OXO）

官方來源