Cleared Traditional

K173789 - Leksell Gamma Knife Perfexion

K173789 is the FDA 510(k) clearance for Leksell Gamma Knife Perfexion by Elekta Instrument AB. It is a Class 2 Radiology device (product code IWB) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K173789 · Elekta Instrument AB · Radiology device
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Mar 2018
Decision
106d
Days
Class 2
Risk

K173789 is an FDA 510(k) clearance for the Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon. 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 March 30, 2018 after a review of 106 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 Instrument AB devices

Submission Details

510(k) Number K173789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2017
Decision Date March 30, 2018
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
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 21
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K173789.
Akesis Galaxy RTx
K200050 · Akesis, Inc. · Feb 2020
Akesis Galaxy
K190844 · Akesis, Inc. · Sep 2019
GammaPod
K180571 · Xcision Medical Systems, LLC · Apr 2018
Leksell GammaPlan
K173791 · Elekta Instrument AB · Feb 2018
Leksell Gamma Knife Icon
K160440 · Elekta Instrument AB · Apr 2016
Leksell Gamma Knife Perfexion
K151159 · Elekta Instrument AB · Oct 2015