CYBERKNIFE SYSTEM


Device Classification Name

accelerator, linear, medical

510(k) Number K011024
Device Name CYBERKNIFE SYSTEM
Original Applicant
ACCURAY, INC.
570 del rey ave.
sunnyvale, 
CA 
94085

Original Contact e. bruce floyd
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 04/04/2001
Decision Date 08/10/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No