FDA 510(k) Application Details - K053485

Device Classification Name	System, Radiation Therapy, Radionuclide   More FDA Info for this Device
510(K) Number	K053485
Device Name	System, Radiation Therapy, Radionuclide
Applicant	MDS NORDION INC. 447 MARCH ROAD OTTAWA, ONTARIO K2K 1X8 CA Other 510(k) Applications for this Company
Contact	ROSS KACHANIWSKY Other 510(k) Applications for this Contact
Regulation Number	892.5750   More FDA Info for this Regulation Number
Classification Product Code	IWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2005
Decision Date	03/09/2006
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