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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 K240769
Device Name LVivo IQS
Applicant
DiA Imaging Analysis Ltd.
HaEnergia Street 77
Beer-Sheva,  IL 8470912
Applicant Contact Michal Yaacobi
Correspondent
Medicsense USA LLC
291 Hillside Avenue
Somerset,  MA  02726
Correspondent Contact George Hattub
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/21/2024
Decision Date 05/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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