FDA 510(k) Application Details - K201247

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K201247
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	Dentium Co., Ltd (ICT Branch) 76, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon-Si 16229 KR Other 510(k) Applications for this Company
Contact	Sangwoo 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	05/11/2020
Decision Date	06/10/2020
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