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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 Doppler, Ultrasonic
510(k) Number K192388
Device Name SonoVision Ultrasound Imaging System
Applicant
Tissue Differentiation Intelligence, LLC
234 NE 4th Ave.
Delray Beach,  FL  33483
Applicant Contact Christian Zaal
Correspondent
Qserve Group, Us, Inc.
303 Twin Dolphin, Suite 600
Redwood Shores,  CA  94065
Correspondent Contact Lorry Weaver Huffman
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/03/2019
Decision Date 03/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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