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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 K240740
Device Name qCT LN Quant
Applicant
Qure.ai Technologies
Level 7, Commerz II International Business Park
Oberoi Garden City, Goregaon (E)
Mumbai,  IN 400 063
Applicant Contact Abishamala Kingsly
Correspondent
Qure.ai Technologies
Level 7, Commerz II International Business Park
Oberoi Garden City, Goregaon (E)
Mumbai,  IN 400 063
Correspondent Contact Abishamala Kingsly
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/18/2024
Decision Date 08/16/2024
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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