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510(k) K173789

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2018
Date Received
December 14, 2017
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)
  • 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)
  • 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)
  • K120811 — LEKSELL GAMMA KNIFE PERFEXION (May 24, 2012)

Other clearances for product code IWB

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  • 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)
  • K173791 — Leksell GammaPlan (February 9, 2018)
  • K172706 — GammaPod - Model A (December 22, 2017)