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510(k) K171837

TomoTherapy Treatment Delivery System with iDMS by Accuray Incorporated — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2017
Date Received
June 20, 2017
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

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