FDA 510(k) Application Details - K213787

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K213787
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm SE10393 SE Other 510(k) Applications for this Company
Contact	Anju Kurian 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	12/06/2021
Decision Date	05/17/2022
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