510(k) K212794

Accuray Precision Treatment Planning System by Accuray Incorporated — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2021
Date Received
September 2, 2021
Clearance Type
Special
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