Cleared Traditional

K041264 - ELEKTA OY

K041264 is an FDA 510(k) clearance for ELEKTA OY, manufactured by Elekta Neuromag OY. The device is a Class 2 Neurology device with product code OLX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K041264 · Elekta Neuromag OY · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
90d
Days
Class 2
Risk

K041264 is an FDA 510(k) clearance for the ELEKTA OY. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Elekta Neuromag OY (Helsinki, FI). The FDA issued a Cleared decision on August 10, 2004 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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.

FDA 510(k) Submission Details - K041264

510(k) Number K041264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2004
Decision Date August 10, 2004
Days to Decision 90 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
59d faster than avg
Panel avg: 149d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLX Device Classification - Class 2, Special Controls

Product Code OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization
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 - OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

All 24
Devices cleared under the same product code (OLX) and FDA review panel - the closest regulatory comparables to K041264.
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
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MAXINSIGHT
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ELEKTA NEUROMAG WITH MAXWELL FILTER
K050035 · Elekta Neuromag OY · Jan 2005
MEGVISION, MODEL EQ1000C SERIES
K040051 · Eagle Technology, Inc. · Mar 2004
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
K030737 · Ctf Systems (2001), Inc. · Oct 2003
NEUROSOFT'S SOURCE
K011241 · Neurosoft, Inc. · Sep 2001
K041264 · ELEKTA OY
Download PDF FDA Summary Elekta Neuromag OY