Cleared Traditional

OEC One CFD

K253269 · Ge Hualun Medical Systems Co. , Ltd. · Radiology

Nov 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K253269 is an FDA 510(k) clearance for the OEC One CFD, a Image-intensified Fluoroscopic X-ray System, Mobile (Class II — Special Controls, product code OXO), submitted by Ge Hualun Medical Systems Co. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 26, 2025, 58 days after receiving the submission on September 29, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K253269 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	November 26, 2025
Days to Decision	58 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.