FDA 510(k) Application Details - K011246

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K011246
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	MDS NORDION 447 MARCH RD. OTTAWA, ONTARIO K2K1X8 CA Other 510(k) Applications for this Company
Contact	E.S. MARTELL Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	MUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2001
Decision Date	05/23/2001
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