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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 K172869
Device Name Discovery XR656 HD
Applicant
Ge Hualun Medical Systems Co. , Ltd.
#1, Yong Chang N. Rd., Beijing Economic Technological
Development Zone
Beijing,  CN 100176
Applicant Contact Kenny Ma
Correspondent
Ge Hualun Medical Systems Co. , Ltd.
#1, Yong Chang N. Rd., Beijing Economic Technological
Development Zone
Beijing,  CN 100176
Correspondent Contact Kenny Ma
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received09/20/2017
Decision Date 10/20/2017
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
Recalls CDRH Recalls
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