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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K241725
Device Name Better Diagnostics Caries Assist (BDCA) Version 1.0
Applicant
Better Diagnostics AI Corp.
29 Alcott Way
Avon,  CT  06001
Applicant Contact Rajeev Nohria
Correspondent
Better Diagnostics AI Corp.
29 Alcott Way
Avon,  CT  06001
Correspondent Contact Rajeev Nohria
Regulation Number892.2070
Classification Product Code
MYN  
Date Received06/14/2024
Decision Date 03/11/2025
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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