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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 K251417
Device Name ReVISION 2
Applicant
Argus Cognitive, Inc.
35 S. Main St.
Hanover,  NH  03755
Applicant Contact Zoltan Toser
Correspondent
Argus Cognitive, Inc.
35 S. Main St.
Hanover,  NH  03755
Correspondent Contact Andrea Marosán
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/07/2025
Decision Date 09/09/2026
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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