Cleared Traditional

LEKSELL GAMMA KNIFE PERFEXION (K133565) - FDA 510(k) Clearance

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

K133565 · Elekta Instrument AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
170d
Days
Class 2
Risk

K133565 is an FDA 510(k) clearance for the LEKSELL GAMMA KNIFE PERFEXION. Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on May 9, 2014 after a review of 170 days - an extended review cycle.

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 Instrument AB devices

Submission Details

510(k) Number K133565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2013
Decision Date May 09, 2014
Days to Decision 170 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 107d · This submission: 170d
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 K133565.
Leksell Gamma Knife® (Elekta Esprit)
K250391 · Elekta Solutions AB · Jul 2025
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