SonoVision Ultrasound Imaging System

System, Imaging, Pulsed Doppler, Ultrasonic

Tissue Differentiation Intelligence, LLC

The following data is part of a premarket notification filed by Tissue Differentiation Intelligence, Llc with the FDA for Sonovision Ultrasound Imaging System.

Pre-market Notification Details

Device IDK192388
510k NumberK192388
Device Name:SonoVision Ultrasound Imaging System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Tissue Differentiation Intelligence, LLC 234 NE 4th Avenue Delray Beach,  FL  33483
ContactChristian Zaal
CorrespondentLorry Weaver Huffman
Qserve Group, US, Inc. 303 Twin Dolphin, Suite 600 Redwood Shores,  CA  94065
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-03
Decision Date2020-03-12

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