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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K200232
Device Name LVivo Software Application
Applicant
DiA Imaging Analysis Ltd
77 Haenergia Street
beer-sheva,  IL 8470912
Applicant Contact michal yaacobi
Correspondent
Medicsense USA
291 Hillside Avenue
somerset,  MA  02726
Correspondent Contact george hattub
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/30/2020
Decision Date 06/23/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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