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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 Triage And Notification Software
510(k) Number K252366
Device Name a2z-Unified-Triage
Applicant
A2z Radiology Ai, Inc.
292 Newbury St.
Unit 235
Boston,  MA  02115
Applicant Contact Samir Rajpurkar
Correspondent
A2z Radiology Ai, Inc.
292 Newbury St.
Unit 235
Boston,  MA  02115
Correspondent Contact Samir Rajpurkar
Regulation Number892.2080
Classification Product Code
QAS  
Subsequent Product Code
QFM  
Date Received07/30/2025
Decision Date 11/24/2025
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		 Yes
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