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510(k) K210500

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD by Elekta Limited — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2021
Date Received
February 22, 2021
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

  • K192482 — Elekta Unity (December 5, 2019)
  • K192242 — Synergy Platform, Synergy, Infinity, VersaHD (November 22, 2019)
  • K182076 — Elekta Unity (December 4, 2018)
  • K153011 — iViewDose R1.0 (December 11, 2015)
  • K131965 — XVI R5.0 (September 25, 2013)
  • K112613 — INTEGRITY(TM) (December 16, 2011)
  • K111676 — APEX (September 30, 2011)

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