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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 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 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
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