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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 K231149
Device Name qXR-CTR
Applicant
Qure.ai Technologies
Level 7, Commerz II, International Business Park
Oberoi Garden City, Goregaon(E)
Mumbai,  IN 400063
Applicant Contact Srinidhi Ragunathan
Correspondent
Qure.ai Technologies
Level 7, Commerz II, International Business Park
Oberoi Garden City, Goregaon(E)
Mumbai,  IN 400063
Correspondent Contact Srinidhi Ragunathan
Regulation Number892.2050
Classification Product Code
QIH  
Date Received04/21/2023
Decision Date 09/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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