FDA 510(k) Application Details - K133524

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K133524
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	PORTAVISION MEDICAL LLC 5401 COCOS PLUMOSAS DRIVE KENNER, LA 70065 US Other 510(k) Applications for this Company
Contact	TERRY ANCAR Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	MQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2013
Decision Date	04/16/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review