FDA 510(k) Application Details - K000478

Device Classification Name System, Radiation Therapy, Radionuclide

  More FDA Info for this Device
510(K) Number K000478
Device Name System, Radiation Therapy, Radionuclide
Applicant ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE, CA 94085 US
Other 510(k) Applications for this Company
Contact LUANNE NG
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 02/14/2000
Decision Date 04/19/2000
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



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