510(k) K052325

CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY by Accuray Incorporated — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2005
Date Received
August 25, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type