FDA 510(k) Application Details - K061582

Device Classification Name System, Applicator, Radionuclide, Remote-Controlled

  More FDA Info for this Device
510(K) Number K061582
Device Name System, Applicator, Radionuclide, Remote-Controlled
Applicant VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY M/S E-110
PALO ALTO, CA 94304 US
Other 510(k) Applications for this Company
Contact VY TRAN
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 06/07/2006
Decision Date 07/25/2006
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