Cleared Traditional

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

K251004 · Hefei Chimed Intelligent Machine Co., Ltd. · Radiology

Nov 2025

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K251004 is an FDA 510(k) clearance for the Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M), a Image-intensified Fluoroscopic X-ray System, Mobile (Class II — Special Controls, product code OXO), submitted by Hefei Chimed Intelligent Machine Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on November 6, 2025, 219 days after receiving the submission on April 1, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K251004 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2025
Decision Date	November 06, 2025
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OXO — Image-intensified Fluoroscopic X-ray System, Mobile
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Fluoroscopy Of The Human Body.