Cleared Traditional

K173789 - Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon

K173789 is an FDA 510(k) clearance for Leksell Gamma Knife Perfexion, manufactured by Elekta Instrument AB. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K173789

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.

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 32
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
GammaPod - Model A
K172706 · Xcision Medical Systems, LLC · Dec 2017
Leksell Gamma Knife Icon
K160440 · Elekta Instrument AB · Apr 2016