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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 K253944
Device Name Data Analysis Facilitation Suite (DAFS)
Applicant
Voronoi Health Analytics Incorporated
#250-997 Seymour St.
Vancouver,  CA V6B 3M1
Applicant Contact Mirza Faisal Beg
Correspondent
Voronoi Health Analytics Incorporated
#250-997 Seymour St.
Vancouver,  CA V6B 3M1
Correspondent Contact Mirza Faisal Beg
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/10/2025
Decision Date 03/16/2026
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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