FDA 510(k) Application Details - K160440

Device Classification Name	System, Radiation Therapy, Radionuclide   More FDA Info for this Device
510(K) Number	K160440
Device Name	System, Radiation Therapy, Radionuclide
Applicant	Elekta Instrument AB Kungstensgatan 18 Stockholm 10393 SE Other 510(k) Applications for this Company
Contact	Alf Laurell 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	02/17/2016
Decision Date	04/20/2016
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