Cleared Traditional

K120811 - LEKSELL GAMMA KNIFE PERFEXION

K120811 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 69-day FDA review.

K120811 · Elekta Instrument AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
69d
Days
Class 2
Risk

K120811 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 24, 2012 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elekta Instrument AB devices

Submission Details

510(k) Number K120811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2012
Decision Date May 24, 2012
Days to Decision 69 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
38d faster than avg
Panel avg: 107d · This submission: 69d
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 K120811.
Leksell Gamma Knife Perfexion
K151159 · Elekta Instrument AB · Oct 2015
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K151561 · Elekta Instrument AB · Aug 2015
LEKSELL GAMMA KNIFE PERFEXION
K133565 · Elekta Instrument AB · May 2014
EXTEND FRAME SYSTEM, MODEL 1009633
K092083 · Elekta Instrument AB · Sep 2009
LEKSELL GAMMA KNIFE PERFEXION
K063512 · Elekta Instrument AB · Mar 2007
LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000
K061941 · Elekta Instrument AB · Aug 2006