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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 K252954
Device Name MammoSightAI
Applicant
Neurocareai, Inc. (Dba Savelife.Ai)
1740 Lonesome Dove Dr.
Prosper,  TX  75078
Applicant Contact Junaid Siddiq Kalia
Correspondent
Neurocareai, Inc. (Dba Savelife.Ai)
1740 Lonesome Dove Dr.
Prosper,  TX  75078
Correspondent Contact Junaid Siddiq Kalia
Regulation Number892.2080
Classification Product Code
QFM  
Date Received09/16/2025
Decision Date 05/04/2026
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		 No
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