Cleared Traditional

K043290 - MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0

K043290 is an FDA 510(k) clearance for MINDSTATE FUNCTIONAL DATA ACQUISITION D..., manufactured by Neurognostics, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K043290 · Neurognostics, Inc. · Radiology device
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Jan 2005
Decision
60d
Days
Class 2
Risk

K043290 is an FDA 510(k) clearance for the MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Neurognostics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 28, 2005 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight 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 Neurognostics, Inc. devices

FDA 510(k) Submission Details - K043290

510(k) Number K043290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2004
Decision Date January 28, 2005
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 Radiology devices follow this clearance model.

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