FDA 510(k) Application Details - K111311

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K111311
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	OMISA INC. (SEGASIST TECHNOLOGIES) 1666 12TH LINE, RR #3 LAKEFIELD, ONTARIO K0L 2H0 CA Other 510(k) Applications for this Company
Contact	ALLISON MANNERS 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	05/10/2011
Decision Date	10/17/2011
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