Cleared Special

K031980 - MODIFICATION TO LEKSELL STEREOTACTIC SY...

K031980 is the FDA 510(k) clearance for MODIFICATION TO LEKSELL STEREOTACTIC SY... by Elekta Instrument AB. It is a Class 2 Radiology device (product code HAW) cleared through the Special 510(k) pathway after a 29-day FDA review.

K031980 · Elekta Instrument AB · Radiology device
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Jul 2003
Decision
29d
Days
Class 2
Risk

K031980 is an FDA 510(k) clearance for the MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Elekta Instrument AB (Stockholm, SE). The FDA issued a Cleared decision on July 25, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 882.4560 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Elekta Instrument AB devices

Submission Details

510(k) Number K031980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2003
Decision Date July 25, 2003
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K031980.
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