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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 K210053
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 Received01/08/2021
Decision Date 02/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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