Cleared Traditional

K040051 - MEGVISION, MODEL EQ1000C SERIES

K040051 is an FDA 510(k) clearance for MEGVISION, manufactured by Eagle Technology, Inc.. The device is a Class 2 Neurology device with product code OLX cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K040051 · Eagle Technology, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
72d
Days
Class 2
Risk

K040051 is an FDA 510(k) clearance for the MEGVISION, MODEL EQ1000C SERIES. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Eagle Technology, Inc. (Santa Fe, US). The FDA issued a Cleared decision on March 24, 2004 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K040051

510(k) Number K040051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2004
Decision Date March 24, 2004
Days to Decision 72 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
77d faster than avg
Panel avg: 149d · This submission: 72d
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 K040051.
MAXINSIGHT
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K030737 · Ctf Systems (2001), Inc. · Oct 2003
NEUROSOFT'S SOURCE
K011241 · Neurosoft, Inc. · Sep 2001
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
K001781 · Neurosoft, Inc. · Feb 2001
K040051 · MEGVISION, MODEL EQ1000C SERIES
Download PDF FDA Summary Eagle Technology, Inc.