Cleared Traditional

K070358 - MAXINSIGHT

K070358 is an FDA 510(k) clearance for MAXINSIGHT, 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 173-day FDA review.

K070358 · Eemagine Medical Imaging Solutions GmbH · Neurology device
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Jul 2007
Decision
173d
Days
Class 2
Risk

K070358 is an FDA 510(k) clearance for the MAXINSIGHT. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Eemagine Medical Imaging Solutions GmbH (Deer Field, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 173 days - an extended review 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: 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.

View all Eemagine Medical Imaging Solutions GmbH devices

FDA 510(k) Submission Details - K070358

510(k) Number K070358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2007
Decision Date July 30, 2007
Days to Decision 173 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
25d slower than avg
Panel avg: 148d · This submission: 173d
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.