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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K182237
Device Name uMI 550 PET/CT System
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 Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received08/17/2018
Decision Date 10/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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