Cleared Traditional

K091393 - ELEKTA NEUROMAG WITH MAXFILTER

K091393 is an FDA 510(k) clearance for ELEKTA NEUROMAG WITH MAXFILTER, 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 533-day FDA review.

K091393 · Elekta Neuromag OY · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
533d
Days
Class 2
Risk

K091393 is an FDA 510(k) clearance for the ELEKTA NEUROMAG WITH MAXFILTER. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Elekta Neuromag OY (Naples, US). The FDA issued a Cleared decision on October 26, 2010 after a review of 533 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K091393

510(k) Number K091393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2009
Decision Date October 26, 2010
Days to Decision 533 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
384d slower than avg
Panel avg: 149d · This submission: 533d
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 K091393.
PreOp
K172858 · Epilog · Jan 2018
GEOSOURCE
K092844 · Electrical Geodesics, Inc. · Dec 2010
STELLATE GRIDVIEW
K100126 · Excel-Tech Ltd. (Xltek) · Dec 2010
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
K081430 · Elekta Neuromag OY · Jul 2008
MAXINSIGHT
K070358 · Eemagine Medical Imaging Solutions GmbH · Jul 2007
ELEKTA NEUROMAG WITH MAXWELL FILTER
K050035 · Elekta Neuromag OY · Jan 2005
K091393 · ELEKTA NEUROMAG WITH MAXFILTER
Download PDF FDA Summary Elekta Neuromag OY