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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
3D-Side SA
Rue André Dumont 5
Mont-Saint-Guibert,  BE 1435
Applicant Contact Laurent Paul
OrthoGrow NV
Davincilaan 1
Zaventem,  BE 1930
Correspondent Contact Mieke Janssen
Regulation Number892.2050
Classification Product Code
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