FDA 510(k) Application Details - K162868

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K162868
Device Name	System, Image Processing, Radiological
Applicant	JPI Healthcare Solutions, 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	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/2016
Decision Date	03/17/2017
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