FDA 510(k) Application Details - K082041

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K082041
Device Name	System, Image Processing, Radiological
Applicant	FIATLUX IMAGING INC. 8430 154TH AVE. NE REDMOND, WA 98052 US Other 510(k) Applications for this Company
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	07/18/2008
Decision Date	08/01/2008
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