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510(k) K131965

XVI R5.0 by Elekta Limited — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2013
Date Received
June 27, 2013
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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