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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K190314
Device Name Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
Applicant
Mednovel Technology, Ltd.
1154 Cadillac Ct.
Milpitas,  CA  95035
Applicant Contact Jia Yu
Correspondent
Mednovel Technology, Ltd.
1154 Cadillac Ct.
Milpitas,  CA  95035
Correspondent Contact Jia Yu
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   LLZ  
Date Received02/13/2019
Decision Date 10/09/2019
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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