FDA 510(k) Application Details - K221144

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K221144
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	Radisen Co., Ltd 14F, 128, 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	04/20/2022
Decision Date	05/13/2022
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