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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K252482
Device Name CogNet AI-MT+
Applicant
Medcognetics, Inc.
17217 Waterview Pkwy.
Suite 1.202e
Dallas,  TX  75252
Applicant Contact John Jenkins
Correspondent
Medcognetics, Inc.
17217 Waterview Pkwy.
Suite 1.202e
Dallas,  TX  75252
Correspondent Contact John Jenkins
Regulation Number892.2080
Classification Product Code
QFM  
Date Received08/07/2025
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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