CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM


Device Classification Name

accelerator, linear, medical

510(k) Number K122137
Device Name CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM
Applicant
ACCURAY INCORPORATED
1310 chesapeake terrace
sunnyvale, 
CA 
94089

Applicant Contact anne schlagenhaft
Correspondent
ACCURAY INCORPORATED
1310 chesapeake terrace
sunnyvale, 
CA 
94089

Correspodent Contact anne schlagenhaft
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 07/18/2012
Decision Date 10/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls