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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K251883
Device Name MIM – LesionID Pro
Applicant
Mim Software, Inc.
25800 Science Park Dr., Suite 180
Cleveland,  OH  44122
Applicant Contact Sydney Lindner
Correspondent
Mim Software, Inc.
25800 Science Park Dr., Suite 180
Cleveland,  OH  44122
Correspondent Contact Sydney Lindner
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/20/2025
Decision Date 12/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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