FDA 510(k) Application Details - K121663

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K121663
Device Name	Accelerator, Linear, Medical
Applicant	ELEKTA LTD. 2050 BLEURY, SUITE 200 MONTREAL H3A 2J5 CA Other 510(k) Applications for this Company
Contact	GEORGE PAPAGIANNIS Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2012
Decision Date	12/05/2012
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