FDA 510(k) Application Details - K160143

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K160143
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	JPI HEALTHCARE, INC WOOLIM E-BIZ CENTER #608, 170-5 KURO 3-DONG, KURO-GU 152-769 KR Other 510(k) Applications for this Company
Contact	JANG WON LEE Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	MQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2016
Decision Date	10/28/2016
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