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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
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