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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
DiA Imaging Analysis Ltd
77 Haenergia Street
Beer-Sheva,  IL 8470912
Applicant Contact Michal Yaacobi
Medicsense USA
291 Hillside Avenue
Somerset,  MA  02726
Correspondent Contact George Hattub
Regulation Number892.2050
Classification Product Code
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