Cleared Traditional

ELEKTA NEUROMAG WITH MAXFILTER (K091393) - FDA 510(k) Clearance

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

K091393 · Elekta Neuromag OY · Neurology device
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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.

View all Elekta Neuromag OY devices

Submission Details

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
Regulatory Context
Review time vs. panel average
385d slower than avg
Panel avg: 148d · This submission: 533d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
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