FDA 510(k) Application Details - K160354

Device Classification Name	More FDA Info for this Device
510(K) Number	K160354
Device Name	MX50T(MX50TQS)
Applicant	WIDE CORPORATION 12 WONGOMAE-RO, GIHEUNG-GU YONGIN-SI 17086 KR 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	02/08/2016
Decision Date	05/02/2016
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