FDA 510(k) Application Details - K220164

Device Classification Name	More FDA Info for this Device
510(K) Number	K220164
Device Name	Rayvolve
Applicant	AZmed SAS 6 rue Leonard de Vinci Laval 53000 FR Other 510(k) Applications for this Company
Contact	Patricia Massako Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2022
Decision Date	06/02/2022
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