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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K223296
Device Name Videa Perio 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 Number892.2050
Classification Product Code
QIH  
Date Received10/26/2022
Decision Date 02/06/2023
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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