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510(k) K051932

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 by Elekta, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2005
Date Received
July 13, 2005
Clearance Type
Special
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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  • K141855 — CLARITY (October 8, 2014)
  • K123808 — AGILITY (April 4, 2013)
  • K121663 — CLARITY (December 5, 2012)
  • K121328 — AGILITY (June 12, 2012)
  • K111332 — CLARITY OBP SYSTEM (January 30, 2012)
  • K102200 — INTEGRITY MODEL 1014284 (November 4, 2010)
  • K100115 — XVI R4.5 (March 10, 2010)

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