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FDA 510(k)

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)

K-Number: K251004 · 2025-11-06

ApplicantHefei Chimed Intelligent Machine Co., Ltd.
Decision Date2025-11-06
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) is a medical device manufactured by Hefei Chimed Intelligent Machine Co., Ltd.. It received FDA 510(k) clearance on 2025-11-06 under approval number K251004. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Hefei Chimed Intelligent Machine Co., Ltd.. The 510(k) number is K251004.

When was Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) approved by the FDA?

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

What company makes Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)?

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) is manufactured by Hefei Chimed Intelligent Machine Co., Ltd..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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