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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 K210001
Device Name HYPER AiR
Applicant
Shanghai United Imaging Healthcare Co.,Ltd.
No. 2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Applicant Contact Xin GAO
Correspondent
Shanghai United Imaging Healthcare Co.,Ltd.
No. 2258 Chengbei Rd., Jiading Industrial District
Shanghai,  CN 201807
Correspondent Contact Xin GAO
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/04/2021
Decision Date 04/30/2021
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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