FDA 510(k) Application Details - K222717

Device Classification Name	More FDA Info for this Device
510(K) Number	K222717
Device Name	CL24N
Applicant	WIDE Corporation 15F, The First Tower III, 602, Dongtangiheung-Ro Hwaseong-Si 18469 CN Other 510(k) Applications for this Company
Contact	YeoJin Yun Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2022
Decision Date	10/31/2022
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