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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 K222970
Device Name LVivo IQS
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 Received09/27/2022
Decision Date 02/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No