Cleared Traditional

K972324 - LEKSELL STEREOTACTIC SYSTEM

K972324 is an FDA 510(k) clearance for LEKSELL STEREOTACTIC SYSTEM, manufactured by Elekta Instrument AB. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K972324 · Elekta Instrument AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
252d
Days
Class 2
Risk

K972324 is an FDA 510(k) clearance for the LEKSELL STEREOTACTIC SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Elekta Instrument AB (San Diego, US). The FDA issued a Cleared decision on March 2, 1998 after a review of 252 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Elekta Instrument AB devices

FDA 510(k) Submission Details - K972324

510(k) Number K972324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1997
Decision Date March 02, 1998
Days to Decision 252 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 148d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

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 Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 331
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K972324.
ATLASPLAN
K980584 · Radionics, Inc. · May 1998
OPTICAL TRACKING SYSTEM (OTS)
K974602 · Radionics Software Applications, Inc. · Apr 1998
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
K973684 · Elekta Instrument AB · Mar 1998
STEALTHSTATION SYSTEM
K974187 · Surgical Navigation Technologies, Inc. · Jan 1998
STEALTHSTATION SYSTEM
K974161 · Surgical Navigation Technologies, Inc. · Nov 1997
CAROLINE GUIDE/DELIA LOCALIZER
K973277 · Surgical Solutions, Inc. · Nov 1997