FDA 510(k) Application Details - K180989

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K180989
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	Radisen Inc. 14F, Gongduk B/D, 11, Saechang-ro, Mapo-gu Seoul 04168 KR Other 510(k) Applications for this Company
Contact	John Lim 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	04/16/2018
Decision Date	06/13/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review