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510(k) K061540

LEKSELL GAMMAPLAN by Elekta Instrument AB — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2006
Date Received
June 5, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Radionuclide
Device Class
Class II
Regulation Number
892.5750
Review Panel
RA
Submission Type

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  • K160440 — Leksell Gamma Knife Icon (April 20, 2016)
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  • K151159 — Leksell Gamma Knife Perfexion (October 29, 2015)
  • K151666 — Leksell GammaPlan (September 3, 2015)
  • K151561 — Leksell Gamma Knife Icon (August 4, 2015)
  • K133565 — LEKSELL GAMMA KNIFE PERFEXION (May 9, 2014)

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  • K173791 — Leksell GammaPlan (February 9, 2018)