Cleared Traditional

K002631 - ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG

K002631 is an FDA 510(k) clearance for ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG, manufactured by Eemagine Medical Imaging Solutions GmbH. The device is a Class 2 Neurology device with product code OLX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K002631 · Eemagine Medical Imaging Solutions GmbH · Neurology device
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Oct 2000
Decision
61d
Days
Class 2
Risk

K002631 is an FDA 510(k) clearance for the ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Eemagine Medical Imaging Solutions GmbH (Mukwonago, US). The FDA issued a Cleared decision on October 23, 2000 after a review of 61 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.

View all Eemagine Medical Imaging Solutions GmbH devices

FDA 510(k) Submission Details - K002631

510(k) Number K002631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2000
Decision Date October 23, 2000
Days to Decision 61 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
88d faster than avg
Panel avg: 149d · This submission: 61d
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 21
Devices cleared under the same product code (OLX) and FDA review panel - the closest regulatory comparables to K002631.
ELEKTA OY
K041264 · Elekta Neuromag OY · Aug 2004
NEUROSOFT'S SOURCE
K011241 · Neurosoft, Inc. · Sep 2001
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
K001781 · Neurosoft, Inc. · Feb 2001
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
K993708 · Biomagnetic Technologies, Inc. · Dec 1999
NEUROMAG VECTORVIEW
K984401 · Philips Medical Systems (Cleveland), Inc. · Dec 1998
IMAGE VUE EEG
K980477 · Sam Technology, Inc. · Aug 1998