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510(k) K232854

Leksell GammaPlan (LGP) by Elekta Solutions AB — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2024
Date Received
September 15, 2023
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

  • K252002 — Monaco RTP System (6.3) (February 19, 2026)
  • K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infin (January 15, 2026)
  • K251363 — ProKnow DS (October 8, 2025)
  • K250391 — Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamm (July 2, 2025)
  • K223233 — Monaco RTP System (February 23, 2023)
  • K223229 — MOSAIQ® OIS (Oncology Information System) (February 23, 2023)
  • K223209 — Elekta Unity (February 23, 2023)
  • K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - E (October 26, 2022)
  • 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)
  • 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)
  • K172706 — GammaPod - Model A (December 22, 2017)