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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 K260300
Device Name WatchMate Software
Applicant
Anumana, Inc.
One Main St., Suite 400
East Arcade 4th Floor
Cambridge,  MA  02142
Applicant Contact Animesh Agarwal
Correspondent
Veranex, Inc.
5420 Wade Park Blvd., Suite 204
Raleigh,  NC  27607
Correspondent Contact Michael Billig
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/30/2026
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Clinical Trials NCT07126600
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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