Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K221432 |
Device Name |
Customize |
Applicant |
3D-Side SA |
Rue Andre Dumont 5 |
Mont-Saint-Guibert,
BE
1435
|
|
Applicant Contact |
Laurent Paul |
Correspondent |
OrthoGrow NV |
Davincilaan 1 |
Zaventem,
BE
1930
|
|
Correspondent Contact |
Mieke Janssen |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/17/2022 |
Decision Date | 08/03/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|