FDA 510(k) Application Details - K222312

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K222312
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	RaySearch Laboratories AB (publ) Eugeniavagen 18 Stockholm 113 68 SE Other 510(k) Applications for this Company
Contact	David Hedfors 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	08/01/2022
Decision Date	03/29/2023
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