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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 K213779
Device Name Customize
Applicant
3D-Side SA
Rue André Dumont 5
Mont-Saint-Guibert,  BE 1435
Applicant Contact Laurent Paul
Correspondent
OrthoGrow NV
Davincilaan 1
Zaventem,  BE 1930
Correspondent Contact Mieke Janssen
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/03/2021
Decision Date 03/16/2022
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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