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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K230039
Device Name uOmnispace
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
# 2258 Chengbei Rd., Jiading District
Jiading Industrial District
Shanghai,  CN 201807
Applicant Contact Gao Xin
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
# 2258 Chengbei Rd., Jiading District
Jiading Industrial District
Shanghai,  CN 201807
Correspondent Contact Gao Xin
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/06/2023
Decision Date 07/20/2023
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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