FDA 510(k) Application Details - K180571

Device Classification Name	System, Radiation Therapy, Radionuclide   More FDA Info for this Device
510(K) Number	K180571
Device Name	System, Radiation Therapy, Radionuclide
Applicant	Xcision Medical Systems, LLC 9176 Red Branch Road Columbia, MD 21045 US Other 510(k) Applications for this Company
Contact	Daniel R. Plonski Other 510(k) Applications for this Contact
Regulation Number	892.5750   More FDA Info for this Regulation Number
Classification Product Code	IWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2018
Decision Date	04/04/2018
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