FDA 510(k) Application Details - K211782

Device Classification Name	More FDA Info for this Device
510(K) Number	K211782
Device Name	ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
Applicant	ControlRad, Inc 275 Scientific Drive NW #1100 Norcross, GA 30092 US Other 510(k) Applications for this Company
Contact	Chris Fair 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	06/09/2021
Decision Date	07/01/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review