Leksell Gamma Knife® (3 models)— 510(k) K250391

Substantially Equivalent

Elekta Solutions AB

FDA 510(k) clearance K250391 for Leksell Gamma Knife® (3 models), Substantially Equivalent on 2025-07-02. Applicant: Elekta Solutions AB. Device class: 2.

Clearance details

Device name as filed: Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)
Applicant: Elekta Solutions AB
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2025-02-12
Decision date: 2025-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWB

K232854 — Leksell GammaPlan (LGP)2024-02-08
K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)2022-10-26
K203250 — TaiChiC2021-03-12
K203146 — Akesis Galaxy RTi2021-03-05
K200050 — Akesis Galaxy RTx2020-02-04

More clearances from Elekta Solutions AB

K261932 — Leksell® Vantage Stereotactic System2026-08-05
K252002 — Monaco RTP System (6.3)2026-02-19
K252188 — EMLA (6 models)2026-01-15
K251363 — ProKnow DS2025-10-08
K223209 — Elekta Unity2023-02-23

Recalls naming K250391

K-number listed on FDA's recall record

Z-1581-2026 — Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.Class II·Ongoing·Elekta, Inc.·20260218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250391.

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