FDA 510(k) Application Details - K151038

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K151038
Device Name	System, X-Ray, Mobile
Applicant	ECOTRON CO.,LTD RM 504, HANSHIN IT TOWER II, 47, DIGITAL-RO 9-GIL GEUMCHEON-GU SEOUL 153-712 KR Other 510(k) Applications for this Company
Contact	SANG BONG LEE Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2015
Decision Date	07/24/2015
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