Cleared Special

K030737 - OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275

K030737 is an FDA 510(k) clearance for OMEGA WHOLE-CORTEX MFG SYSTEM, manufactured by Ctf Systems (2001), Inc.. The device is a Class 2 Neurology device with product code OLX cleared through the Special 510(k) pathway after a 214-day FDA review.

K030737 · Ctf Systems (2001), Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
214d
Days
Class 2
Risk

K030737 is an FDA 510(k) clearance for the OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Ctf Systems (2001), Inc. (Port Coquitlam, B.C., CA). The FDA issued a Cleared decision on October 10, 2003 after a review of 214 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. 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. Standard predicate reliance. 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 - K030737

510(k) Number K030737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2003
Decision Date October 10, 2003
Days to Decision 214 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
65d slower than avg
Panel avg: 149d · This submission: 214d
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 K030737.
ELEKTA NEUROMAG WITH MAXWELL FILTER
K050035 · Elekta Neuromag OY · Jan 2005
ELEKTA OY
K041264 · Elekta Neuromag OY · Aug 2004
MEGVISION, MODEL EQ1000C SERIES
K040051 · Eagle Technology, Inc. · Mar 2004
NEUROSOFT'S SOURCE
K011241 · Neurosoft, Inc. · Sep 2001
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
K001781 · Neurosoft, Inc. · Feb 2001
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
K002631 · Eemagine Medical Imaging Solutions GmbH · Oct 2000
K030737 · OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
Download PDF FDA Summary Ctf Systems (2001), I…