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510(k) K222047

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) by Elekta Solutions AB — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2022
Date Received
July 12, 2022
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 Solutions AB

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  • K250391 — Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamm (July 2, 2025)
  • K232854 — Leksell GammaPlan (LGP) (February 8, 2024)
  • K223229 — MOSAIQ® OIS (Oncology Information System) (February 23, 2023)
  • K223233 — Monaco RTP System (February 23, 2023)
  • K223209 — Elekta Unity (February 23, 2023)
  • K213787 — Monaco RTP System (May 17, 2022)
  • K212218 — Advanced Algorithms for Treatment Management Applications (AATMA) (October 25, 2021)

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)
  • 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)
  • K172706 — GammaPod - Model A (December 22, 2017)