510(k) K122137

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM by Accuray Incorporated — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2012
Date Received
July 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type