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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 K191699
Device Name Discovery XR656 HD with VolumeRad
Applicant
Ge Hualun Medical Systems Co. , Ltd.
# 1 Yong Chang N. Rd., Economic Technological
Development Zone
Beijing,  CN 100176
Applicant Contact Chris Paulik
Correspondent
Ge Hualun Medical Systems Co. , Ltd.
# 1 Yong Chang N. Rd., Economic Technological
Development Zone
Beijing,  CN 100176
Correspondent Contact Chris Paulik
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Codes
IZF   MQB  
Date Received06/25/2019
Decision Date 07/24/2019
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
Recalls CDRH Recalls
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