Devices · Ge Hualun Medical Systems Co. , Ltd.

OEC One CFD

Ge Hualun Medical Systems Co. , Ltd. is listed for OEC One CFD (K253269). The FDA list gives November 26, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OXO as “Image-Intensified Fluoroscopic X-Ray System, Mobile”: Fluoroscopy of the human body. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253269

Official FDA database record

Date of final decision

November 26, 2025

Company on the FDA list

Ge Hualun Medical Systems Co. , Ltd.

Lead panel

Radiology

Primary product code

OXO

openFDA device name for the code

Image-Intensified Fluoroscopic X-Ray System, Mobile

Device class

2

Regulation number

892.1650

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary