Cleared Traditional

K250391 - Leksell Gamma Knife® (Elekta Esprit) (FDA 510(k) Clearance)

Also includes:
Leksell Gamma Knife® (Icon™) Leksell Gamma Knife® (Perfexion™)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 47
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