FDA 510(k) Application Details - K212159

Device Classification Name	More FDA Info for this Device
510(K) Number	K212159
Device Name	Shield System
Applicant	Radiaction Ltd. 10 Hanechoshet St. Tel Aviv 69710 IL Other 510(k) Applications for this Company
Contact	Jonathan Yifat Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2021
Decision Date	03/30/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review