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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 Prioritization Software For Lesions
510(k) Number K230899
Device Name qXR-PTX-PE
Applicant
Qure.ai Technologies
Level 7, Commerz II, International Business Park
Oberoi Garden City, Goregaon (E)
Mumbai,  IN 400063
Applicant Contact Ayushi Mahendra
Correspondent
Qure.ai Technologies
Level 7, Commerz II, International Business Park
Oberoi Garden City, Goregaon (E)
Mumbai,  IN 400063
Correspondent Contact Ayushi Mahendra
Regulation Number892.2080
Classification Product Code
QFM  
Date Received03/31/2023
Decision Date 08/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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