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510(k) K151159

Leksell Gamma Knife Perfexion by Elekta Instrument AB — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2015
Date Received
May 1, 2015
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

Other clearances by Elekta Instrument AB

  • K190887 — Leksell Vantage Stereotactic System (August 1, 2019)
  • K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (March 30, 2018)
  • K173791 — Leksell GammaPlan (February 9, 2018)
  • K171123 — Leksell Vantage Stereotactic System (September 15, 2017)
  • K160440 — Leksell Gamma Knife Icon (April 20, 2016)
  • K152558 — Leksell Stereotactic System, Injection/ Aspiration Needle Kit (March 2, 2016)
  • K151666 — Leksell GammaPlan (September 3, 2015)
  • K151561 — Leksell Gamma Knife Icon (August 4, 2015)
  • K133565 — LEKSELL GAMMA KNIFE PERFEXION (May 9, 2014)
  • K120811 — LEKSELL GAMMA KNIFE PERFEXION (May 24, 2012)

Other clearances for product code IWB

  • K250391 — Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamm (July 2, 2025)
  • K232854 — Leksell GammaPlan (LGP) (February 8, 2024)
  • K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - E (October 26, 2022)
  • K203250 — TaiChiC (March 12, 2021)
  • K203146 — Akesis Galaxy RTi (March 5, 2021)
  • K200050 — Akesis Galaxy RTx (February 4, 2020)
  • K190844 — Akesis Galaxy (September 4, 2019)
  • K180571 — GammaPod (April 4, 2018)
  • K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (March 30, 2018)
  • K173791 — Leksell GammaPlan (February 9, 2018)