Cleared Traditional

K133565 - LEKSELL GAMMA KNIFE PERFEXION

K133565 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 170-day FDA review.

K133565 · Elekta Instrument AB · Radiology device
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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
Combination Product No
PCCP Authorized No
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 21
Devices cleared under the same product code (IWB) and FDA review panel - the closest regulatory comparables to K133565.
Leksell Gamma Knife Icon
K160440 · Elekta Instrument AB · Apr 2016
Leksell Gamma Knife Perfexion
K151159 · Elekta Instrument AB · Oct 2015
Leksell Gamma Knife Icon
K151561 · Elekta Instrument AB · Aug 2015
LEKSELL GAMMA KNIFE PERFEXION
K120811 · Elekta Instrument AB · May 2012
EXTEND FRAME SYSTEM, MODEL 1009633
K092083 · Elekta Instrument AB · Sep 2009
LEKSELL GAMMA KNIFE PERFEXION
K063512 · Elekta Instrument AB · Mar 2007