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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 K253535
Device Name Ligence Heart
Applicant
Ligence Uab
Taikos Pr. 54
Kaunas,  LT 51305
Applicant Contact Alvaro Perez-Moreno
Correspondent
Arazy Group Consultants, Inc.
3422 Leonardo Lane
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/13/2025
Decision Date 02/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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