Cleared Traditional

K133565 - LEKSELL GAMMA KNIFE PERFEXION

K133565 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 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

FDA 510(k) Submission Details - K133565

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.

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 K133565.
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