FDA 510(k) Application Details - K183037

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K183037
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	Elekta, Inc 13723 Riverport Drive, Suite 100 Maryland Heights, MO 63043 US Other 510(k) Applications for this Company
Contact	Kathryn Stinson 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	11/01/2018
Decision Date	12/04/2018
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