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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 Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K261517
Device Name qCT Lung (v1.0)
Applicant
Qure.Ai Technologies Pvt. , Ltd.
6th Floor, Wing E, Times Sq., Andheri- Kurla Rd., Marol
Andheri (East)
Mumbai,  IN 400059
Applicant Contact Smina T P
Correspondent
Qure.Ai Technologies Pvt. , Ltd.
6th Floor, Wing E, Times Sq., Andheri- Kurla Rd., Marol
Andheri (East)
Mumbai,  IN 400059
Correspondent Contact Smina T P
Classification Product Code
QDQ  
Date Received05/07/2026
Decision Date 09/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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