FDA 510(k) Application Details - K133247

Device Classification Name System,Planning,Radiation Therapy Treatment

  More FDA Info for this Device
510(K) Number K133247
Device Name System,Planning,Radiation Therapy Treatment
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 892.5050

  More FDA Info for this Regulation Number
Classification Product Code MUJ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/22/2013
Decision Date 02/07/2014
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact