Cleared Traditional

LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 (K984328) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984328 · Elekta Instrument AB · Radiology device
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Optimized for regulatory review, auditing and printing
May 1999
Decision
169d
Days
Class 2
Risk

K984328 is an FDA 510(k) clearance for the LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001. Classified as System, Radiation Therapy, Radionuclide (product code IWB), Class II - Special Controls.

Submitted by Elekta Instrument AB (San Diego, US). The FDA issued a Cleared decision on May 21, 1999 after a review of 169 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 K984328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1998
Decision Date May 21, 1999
Days to Decision 169 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 107d · This submission: 169d
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 47
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