Leksell GammaPlan (LGP)— 510(k) K232854

Substantially Equivalent

Elekta Solutions AB

FDA 510(k) clearance K232854 for Leksell GammaPlan (LGP), Substantially Equivalent on 2024-02-08. Applicant: Elekta Solutions AB. Device class: 2.

Clearance details

Applicant: Elekta Solutions AB
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2023-09-15
Decision date: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWB

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K203250 — TaiChiC2021-03-12
K203146 — Akesis Galaxy RTi2021-03-05
K200050 — Akesis Galaxy RTx2020-02-04

More clearances from Elekta Solutions AB

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K251363 — ProKnow DS2025-10-08
K223209 — Elekta Unity2023-02-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.