FDA 510(k)

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

N.º K: K251004 · 2025-11-06

SolicitanteHefei Chimed Intelligent Machine Co., Ltd.

Fecha de decisión2025-11-06

Código de productoOXO

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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