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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 K251167
Device Name uDR Aurora CX
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
No.2258 Chengbei Rd. Jiading District
Shanghai,  CN 201807
Applicant Contact Xin Gao
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
No.2258 Chengbei Rd. Jiading District
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.1680
Classification Product Code
KPR  
Date Received04/15/2025
Decision Date 09/19/2025
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
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