FDA 510(k) Application Details - K192939

Device Classification Name	Cabinet,X-Ray System   More FDA Info for this Device
510(K) Number	K192939
Device Name	Cabinet,X-Ray System
Applicant	Clarix Imaging 2242 Harrison St Suite 201 Chicago, IL 60612 US Other 510(k) Applications for this Company
Contact	Xiao han Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	MWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2019
Decision Date	12/27/2019
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