FDA 510(k) Application Details - K213779

Device Classification Name	More FDA Info for this Device
510(K) Number	K213779
Device Name	Customize
Applicant	3D-Side SA Rue AndrΘ Dumont 5 Mont-Saint-Guibert 1435 BE Other 510(k) Applications for this Company
Contact	Laurent Paul Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2021
Decision Date	03/16/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review