FDA 510(k) Application Details - K173309

Device Classification Name	Cabinet,X-Ray System   More FDA Info for this Device
510(K) Number	K173309
Device Name	Cabinet,X-Ray System
Applicant	Faxitron Bioptics Llc 3440 E. Britannia Dr. Suite 150 Tucson, AZ 85706 US Other 510(k) Applications for this Company
Contact	Douglas C. Wiegman 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	10/18/2017
Decision Date	05/09/2018
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