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510(k) K192482

Elekta Unity by Elekta Limited — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2019
Date Received
September 10, 2019
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

Other clearances by Elekta Limited

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  • K131965 — XVI R5.0 (September 25, 2013)
  • K112613 — INTEGRITY(TM) (December 16, 2011)
  • K111676 — APEX (September 30, 2011)

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