LVivo Software Application

Automated Radiological Image Processing Software

DiA Imaging Analysis Ltd

The following data is part of a premarket notification filed by Dia Imaging Analysis Ltd with the FDA for Lvivo Software Application.

Pre-market Notification Details

Device IDK210053
510k NumberK210053
Device Name:LVivo Software Application
ClassificationAutomated Radiological Image Processing Software
Applicant DiA Imaging Analysis Ltd 77 Haenergia Street Beer-sheva,  IL 8470912
ContactMichal Yaacobi
CorrespondentGeorge Hattub
Medicsense USA 291 Hillside Avenue Somerset,  MA  02726
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-08
Decision Date2021-02-05

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