Cleared Traditional

K043309 - GEODESIC PHOTOGRAMMETRY SYSTEM

K043309 is an FDA 510(k) clearance for GEODESIC PHOTOGRAMMETRY SYSTEM, manufactured by Electrical Geodesics, Incorporated. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K043309 · Electrical Geodesics, Incorporated · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 2005
Decision
56d
Days
Class 2
Risk

K043309 is an FDA 510(k) clearance for the GEODESIC PHOTOGRAMMETRY SYSTEM. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Electrical Geodesics, Incorporated (Eugene, US). The FDA issued a Cleared decision on January 26, 2005 after a review of 56 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 Electrical Geodesics, Incorporated devices

FDA 510(k) Submission Details - K043309

510(k) Number K043309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2004
Decision Date January 26, 2005
Days to Decision 56 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
92d faster than avg
Panel avg: 148d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 119
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