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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 K232384
Device Name Videa Dental Assist
Applicant
Videahealth, Inc.
179 S. St.
Floor 5
Boston,  MA  02111
Applicant Contact Adam Foresman
Correspondent
Videahealth, Inc.
179 S. St.
Floor 5
Boston,  MA  02111
Correspondent Contact Adam Foresman
Regulation Number892.2070
Classification Product Code
MYN  
Date Received08/08/2023
Decision Date 12/15/2023
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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