FDA 510(k) Application Details - K183109

Device Classification Name	More FDA Info for this Device
510(K) Number	K183109
Device Name	ControlRad Trace Model 8
Applicant	ControlRad, Inc. 150 N. Radnor Chester Road, Suite F-200 Radnor, PA 19087 US Other 510(k) Applications for this Company
Contact	Guillaume Bailliard 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	11/08/2018
Decision Date	05/13/2019
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