FDA 510(k) Application Details - K120811

Device Classification Name	System, Radiation Therapy, Radionuclide   More FDA Info for this Device
510(K) Number	K120811
Device Name	System, Radiation Therapy, Radionuclide
Applicant	ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 STOCKHOLM S-103 93 SE Other 510(k) Applications for this Company
Contact	VIVEKA WRETMAN 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	03/16/2012
Decision Date	05/24/2012
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