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510(k) K161136

Precision Treatment Planning System by Accuray Incorporated — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2016
Date Received
April 22, 2016
Clearance Type
Traditional
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

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