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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, Tomography, Computed
510(k) Number K200016
Device Name uCT 530, uCT 550
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Applicant Contact Xin Gao
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/03/2020
Decision Date 02/25/2020
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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