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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K143270
Device Name Optima XR646
Applicant
Ge Hualun Medical Systems Co. , Ltd.
#1, Yong Chang N. Rd.
Economic & Technology Development Zone
Beijing,  CN 100176
Applicant Contact Kenny Ma
Correspondent
Ge Hualun Medical Systems Co. , Ltd.
#1, Yong Chang N. Rd.
Economic & Technology Development Zone
Beijing,  CN 100176
Correspondent Contact Kenny Ma
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received11/13/2014
Decision Date 02/18/2015
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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