FDA 510(k) Application Details - K063512

Device Classification Name	System, Radiation Therapy, Radionuclide   More FDA Info for this Device
510(K) Number	K063512
Device Name	System, Radiation Therapy, Radionuclide
Applicant	ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 PO BOX 7593 STOCKHOLM SE-103 93 SE Other 510(k) Applications for this Company
Contact	ANDERS SKOGLUND 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	11/20/2006
Decision Date	03/05/2007
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