FDA 510(k) Application Details - K153583

Device Classification Name	Cabinet,X-Ray System   More FDA Info for this Device
510(K) Number	K153583
Device Name	Cabinet,X-Ray System
Applicant	FAXITRON BIOPTICS LLC 3440 E. BRITANNIA DRIVE SUITE 150 TUCSON, AZ 85743 US Other 510(k) Applications for this Company
Contact	CARLOS REYES 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	12/15/2015
Decision Date	04/01/2016
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