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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K223687
Device Name X-ray Flat Panel Detectors (EverestView 4343X)
Applicant
Careray Digital Medical Technology Co., Ltd.
A2-201/B3-501, Biobay 218 Xinghu St.,
Suzhou Industrial Park
Suzhou,  CN 215123
Applicant Contact Xu Wei
Correspondent
Careray Digital Medical Technology Co., Ltd.
A2-201/B3-501, Biobay 218 Xinghu St.,
Suzhou Industrial Park
Suzhou,  CN 215123
Correspondent Contact Xu Wei
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
JAA  
Date Received12/09/2022
Decision Date 12/30/2022
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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