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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 K251610
Device Name qER-CTA (v1.0)
Applicant
Qure.Ai Technologies
6th Floor, Wing E, Times Square, Andheri- Kurla Rd., Marol,
Andheri
Mumbai,  IN 400059
Applicant Contact Rajesh Sukhija
Correspondent
Qure.Ai Technologies
6th Floor, Wing E, Times Square, Andheri- Kurla Rd., Marol,
Andheri
Mumbai,  IN 400059
Correspondent Contact Rajesh Sukhija
Regulation Number892.2080
Classification Product Code
QAS  
Date Received05/27/2025
Decision Date 09/08/2025
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		 No
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