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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K251934
Device Name qXR-Detect
Applicant
Qure.Ai Technologies
6th Floor, Wing E, Times Square, Andheri- Kurla Rd., Marol
Andheri (East)
Mumbai,  IN 400059
Applicant Contact Sri Anusha Matta
Correspondent
Qure.Ai Technologies
6th Floor, Wing E, Times Square, Andheri- Kurla Rd., Marol
Andheri (East)
Mumbai,  IN 400059
Correspondent Contact Sri Anusha Matta
Regulation Number892.2070
Classification Product Code
MYN  
Date Received06/24/2025
Decision Date 01/16/2026
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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