FDA 510(k) Application Details - K082386

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K082386
Device Name	System, Image Processing, Radiological
Applicant	SUPERDIMENSION, LTD. 161 CHESHIRE LANE NORTH, SUITE 100 MINNEAPOLIS, MN 55441-5433 US Other 510(k) Applications for this Company
Contact	MARGARET DEPUYDT 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	08/19/2008
Decision Date	09/16/2008
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