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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 K251002
Device Name Videa Dental AI
Applicant
VideaHealth Inc.
179 South Street
Floor 5
Boston,  MA  02111
Applicant Contact Adam Foresman
Correspondent
VideaHealth Inc.
179 South Street
Floor 5
Boston,  MA  02111
Correspondent Contact Adam Foresman
Regulation Number892.2070
Classification Product Code
MYN  
Date Received04/01/2025
Decision Date 09/19/2025
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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