FDA 510(k) Application Details - K111676

Device Classification Name	Block, Beam-Shaping, Radiation Therapy   More FDA Info for this Device
510(K) Number	K111676
Device Name	Block, Beam-Shaping, Radiation Therapy
Applicant	Elekta Limited LINAC HOUSE, FLEMING WAY CRAWLEY RH10 9RR GB Other 510(k) Applications for this Company
Contact	Patrick Hull Other 510(k) Applications for this Contact
Regulation Number	892.5710   More FDA Info for this Regulation Number
Classification Product Code	IXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2011
Decision Date	09/30/2011
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