FDA 510(k) Application Details - K192364

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K192364
Device Name	System, X-Ray, Stationary
Applicant	DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro Gwangmyeong-si 14322 KR Other 510(k) Applications for this Company
Contact	Ki-Nam Yang Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2019
Decision Date	09/26/2019
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