FDA 510(k) Application Details - K053301

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K053301
Device Name	System, Image Processing, Radiological
Applicant	CEDARA SOFTWARE CORP. 6509 AIRPORT RD. MISSISSAUGA, ONTARIO L4V 1S7 CA Other 510(k) Applications for this Company
Contact	CAROL NAKAGAWA 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	11/28/2005
Decision Date	02/03/2006
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	N
Expedited Review