FDA 510(k) Application Details - K020294

Device Classification Name Accelerator, Linear, Medical

  More FDA Info for this Device
510(K) Number K020294
Device Name Accelerator, Linear, Medical
Applicant ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE, CA 94085 US
Other 510(k) Applications for this Company
Contact DONALD E CADDES
Other 510(k) Applications for this Contact
Regulation Number 892.5050

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

  More FDA Info for this Product Code
Date Received 01/28/2002
Decision Date 04/22/2002
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