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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 K200921
Device Name qER
Applicant
Qure.Ai Technologies
Level 7, Commerz Ii, International Business Park,
Oberoi Garden City,
Mumbai,  IN 400063
Applicant Contact Pooja Rao
Correspondent
Qure.Ai Technologies
Level 7, Commerz Ii, International Business Park,
Oberoi Garden City,
Mumbai,  IN 400063
Correspondent Contact Pooja Rao
Regulation Number892.2080
Classification Product Code
QAS  
Date Received04/06/2020
Decision Date 06/17/2020
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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