FDA 510(k) Application Details - K193240

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K193240
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	Varian Medical Systems, Inc. 911 Hansen Way Palo Alto, CA 94304 US Other 510(k) Applications for this Company
Contact	Peter J. Coronado Other 510(k) Applications for this Contact
Regulation Number	892.5700   More FDA Info for this Regulation Number
Classification Product Code	JAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2019
Decision Date	08/17/2020
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