FDA 510(k) Application Details - K162497

Device Classification Name	More FDA Info for this Device
510(K) Number	K162497
Device Name	5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
Applicant	EIZO CORPORATION 153 SHIMOKASHIWANO HAKUSAN 924-8566 JP Other 510(k) Applications for this Company
Contact	Hiroaki Hashimoto 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	09/07/2016
Decision Date	09/19/2016
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