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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 K220080
Device Name CogNet QmTRIAGE
Applicant
MedCognetics, Inc.
17217 Waterview Parkway
Suite 1.202E
Dallas,  TX  75252
Applicant Contact Diane Rutherford
Correspondent
MedCognetics, Inc.
17217 Waterview Parkway
Suite 1.202E
Dallas,  TX  75252
Correspondent Contact Diane Rutherford
Regulation Number892.2080
Classification Product Code
QFM  
Date Received01/10/2022
Decision Date 09/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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