FDA 510(k) Application Details - K160579

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K160579
Device Name	System, Image Processing, Radiological
Applicant	RAYENCE CO., LTD 14, SAMSUNG 1-RO, 1-GIL Hwaseong-si 445-170 KR Other 510(k) Applications for this Company
Contact	Kevin Kim 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	03/01/2016
Decision Date	04/08/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review