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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 K231892
Device Name Definium Pace Select
Applicant
Ge Hualun Medical Systems Co. , Ltd.
#1, Yong Chang N. Rd., Beijing Economic Technological
Development Zone
Beijing,  CN 100176
Applicant Contact Miny Liu
Correspondent
Ge Hualun Medical Systems Co. , Ltd.
#1, Yong Chang N. Rd., Beijing Economic Technological
Development Zone
Beijing,  CN 100176
Correspondent Contact Miny Liu
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received06/28/2023
Decision Date 09/12/2023
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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