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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K193207
Device Name TaiChiA
Applicant
Our United Corporation
3rd Floor, Unit 1, Block 28, Shouchuang International
Business Center, #66
Xi'An,  CN 710018
Applicant Contact Qi Liu
Correspondent
Our United Corporation
3rd Floor, Unit 1, Block 28, Shouchuang International
Business Center, #66
Xi'An,  CN 710018
Correspondent Contact Qi Liu
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/20/2019
Decision Date 08/07/2020
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
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