FDA 510(k) Application Details - K081109

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K081109
Device Name	System, Image Processing, Radiological
Applicant	BARCOVIEW, MEDICAL IMAGING SYSTEMS 35 PRESIDENT KENNEDYPARK KORTRIJK B-8500 BE Other 510(k) Applications for this Company
Contact	NEIL PHILLIPS Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2008
Decision Date	05/02/2008
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	Y
Expedited Review