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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 K212690
Device Name qXR-BT
Applicant
Qure.Ai Technologies
Level 7, Commerz Ii International Business Park
Oberoi Garden City, Goregaon (E)
Mumbai,  IN 400 063
Applicant Contact Bunty Kundnani
Correspondent
Qure.Ai Technologies
Level 7, Commerz Ii International Business Park
Oberoi Garden City, Goregaon (E)
Mumbai,  IN 400 063
Correspondent Contact Bunty Kundnani
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/25/2021
Decision Date 12/21/2021
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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