FDA 510(k) Application Details - K231612

Device Classification Name	Couch, Radiation Therapy, Powered   More FDA Info for this Device
510(K) Number	K231612
Device Name	Couch, Radiation Therapy, Powered
Applicant	Leo Cancer Care 7921 UW Health Court Middleton, WI 53562 US Other 510(k) Applications for this Company
Contact	Graham Lukey Other 510(k) Applications for this Contact
Regulation Number	892.5770   More FDA Info for this Regulation Number
Classification Product Code	JAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2023
Decision Date	05/07/2024
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