FDA 510(k) Application Details - K173425

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K173425
Device Name	System, Therapeutic, X-Ray
Applicant	Sensus Healthcare, Inc. 851 Broken Sound Parkway NW Suite 215 Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Nicolas Soro Other 510(k) Applications for this Contact
Regulation Number	892.5900   More FDA Info for this Regulation Number
Classification Product Code	JAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2017
Decision Date	03/23/2018
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