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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K202847
Device Name AccuBrain
Applicant
Brainnow Medical Technology Limited
Unit 201, 2/F, Lakeside 2, # 10 Science Park W. Ave.,
Hong Kong Science Park, Shatin, N.T.
Hong Kong,  CN 999077
Applicant Contact Junbing Huang
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.1711, Bldg. K, #101 Science Ave.
International Creative Valley
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/25/2020
Decision Date 01/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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