FDA 510(k) Application Details - K160857

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K160857
Device Name	System, X-Ray, Stationary
Applicant	ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION 5220 WALLER ST. STE 1 CRYSTAL LAKE, IL 60012 US Other 510(k) Applications for this Company
Contact	GUIDO ARQUILLA 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	03/29/2016
Decision Date	02/24/2017
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