FDA 510(k) Application Details - K073670

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K073670
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	OREX COMPUTED RADIOGRAPHY LTD STAR YOKNEAM BLDG P.O. BOX 505 YOKNEAM 20692 IL Other 510(k) Applications for this Company
Contact	DAN LAOR 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	12/27/2007
Decision Date	01/25/2008
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