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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 K213795
Device Name Videa Caries Assist
Applicant
Videahealth, Inc.
19 Kingston St.
Boston,  MA  02111
Applicant Contact Florian Hillen
Correspondent
Biologics Consulting
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number892.2070
Classification Product Code
MYN  
Date Received12/06/2021
Decision Date 04/21/2022
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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