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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 K223322
Device Name Argus Cognitive ReVISION Software
Applicant
Argus Cognitive, Inc.
Dartmouth Regional Technical Center
16 Cavendish Ct.
Lebanon,  NH  03766
Applicant Contact Attila Meretei
Correspondent
Argus Cognitive, Inc.
Dartmouth Regional Technical Center
16 Cavendish Ct.
Lebanon,  NH  03766
Correspondent Contact Andrea Marosan
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/31/2022
Decision Date 07/24/2023
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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