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510(k) K061941

LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 by Elekta Instrument AB — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2006
Date Received
July 10, 2006
Clearance Type
Traditional
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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  • 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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