Cleared Special

K050035 - ELEKTA NEUROMAG WITH MAXWELL FILTER

K050035 is an FDA 510(k) clearance for ELEKTA NEUROMAG WITH MAXWELL FILTER, manufactured by Elekta Neuromag OY. The device is a Class 2 Neurology device with product code OLX cleared through the Special 510(k) pathway after a 18-day FDA review.

K050035 · Elekta Neuromag OY · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
18d
Days
Class 2
Risk

K050035 is an FDA 510(k) clearance for the ELEKTA NEUROMAG WITH MAXWELL FILTER. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Elekta Neuromag OY (Stockholm, SE). The FDA issued a Cleared decision on January 25, 2005 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050035

510(k) Number K050035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2005
Decision Date January 25, 2005
Days to Decision 18 days
Submission Type Special
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
131d faster than avg
Panel avg: 149d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 K050035.
ELEKTA NEUROMAG WITH MAXFILTER
K091393 · Elekta Neuromag OY · Oct 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 OY
K041264 · Elekta Neuromag OY · Aug 2004
MEGVISION, MODEL EQ1000C SERIES
K040051 · Eagle Technology, Inc. · Mar 2004
OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
K030737 · Ctf Systems (2001), Inc. · Oct 2003
K050035 · ELEKTA NEUROMAG WITH MAXWELL FILTER
Download PDF FDA Summary Elekta Neuromag OY