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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K253269
Device Name OEC One CFD
Applicant
Ge Hualun Medical Systems Co. , Ltd.
# 1 Yong Chang N. Rd., Economic Technological
Development Zone
Beijing,  CN 100176
Applicant Contact Lifeng Wang
Correspondent
Ge Hualun Medical Systems Co. , Ltd.
# 1 Yong Chang N. Rd., Economic Technological
Development Zone
Beijing,  CN 100176
Correspondent Contact Lifeng Wang
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
JAA   OWB   QIH  
Date Received09/29/2025
Decision Date 11/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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