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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 K181413
Device Name uDR 592h, uDR 596i
Applicant
Shanghai United Imaging Healthcare Co.,Ltd.
No. 2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Applicant Contact Shumei Wang
Correspondent
Shanghai United Imaging Healthcare Co.,Ltd.
No. 2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Correspondent Contact Shumei Wang
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received05/30/2018
Decision Date 06/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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