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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 K233186
Device Name uOmnispace.MR
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Road. Jiading District
Shanghai,  CN 201807
Applicant Contact Gao Xin
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Road. Jiading District
Shanghai,  CN 201807
Correspondent Contact Gao Xin
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LNH  
Date Received09/28/2023
Decision Date 04/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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