FDA 510(k) Application Details - DEN220014

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220014
Device Name	RefleXion Medical Radiotherapy System (RMRS)
Applicant	RefleXion Medical Inc 25841 Industrial Boulevard, Suite 275 Hayward, CA 94545 US Other 510(k) Applications for this Company
Contact	Kathy O'Shaughnessy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2022
Decision Date	02/01/2023
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review