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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 K171800
Device Name OEC Elite MiniView
Applicant
Ge Hualun Medical Systems Co. , Ltd.
No1 Yongchang N. Rd.
Beijing Economic Technological Development Zone
Beijing,  CN 100176
Applicant Contact Lifeng Wang
Correspondent
Ge Hualun Medical Systems Co. , Ltd.
No1 Yongchang N. Rd.
Beijing Economic Technological Development Zone
Beijing,  CN 100176
Correspondent Contact Lifeng Wang
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received06/16/2017
Decision Date 07/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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