FDA 510(k) Application Details - K081093

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K081093
Device Name	System, Image Processing, Radiological
Applicant	EIGEN LLC 13366 GRASS VALLEY AVE. GRASS VALLEY, CA 95945 US Other 510(k) Applications for this Company
Contact	MARK A HOFFMAN 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	04/17/2008
Decision Date	05/01/2008
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	Y
Expedited Review