Cleared Traditional

K250391 - Leksell Gamma Knife (Elekta Esprit)

Also marketed or referenced as:
Leksell Gamma Knife® (Icon™) Leksell Gamma Knife® (Perfexion™)

K250391 is an FDA 510(k) clearance for Leksell Gamma Knife (Elekta Esprit), manufactured by Elekta Solutions AB. The device is a Class 2 Radiology device with product code IWB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K250391 · Elekta Solutions AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
140d
Days
Class 2
Risk

K250391 is an FDA 510(k) clearance for the Leksell Gamma Knife® (Elekta Esprit). Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on July 2, 2025 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Elekta Solutions AB devices

FDA 510(k) Submission Details - K250391

510(k) Number K250391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2025
Decision Date July 02, 2025
Days to Decision 140 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IWB Device Classification - Class 2, Special Controls

Product Code IWB System, Radiation Therapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IWB System, Radiation Therapy, Radionuclide

All 21
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K250391.
Leksell GammaPlan (LGP)
K232854 · Elekta Solutions AB · Feb 2024
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
K222047 · Elekta Solutions AB · Oct 2022
TaiChiC
K203250 · Our United Corporation · Mar 2021
Akesis Galaxy RTi
K203146 · Akesis, Inc. · Mar 2021
Akesis Galaxy RTx
K200050 · Akesis, Inc. · Feb 2020
Akesis Galaxy
K190844 · Akesis, Inc. · Sep 2019