Cleared Traditional

K080762 - IB NEURO

K080762 is the FDA 510(k) clearance for IB NEURO by Imaging Biometrics, LLC. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K080762 · Imaging Biometrics, LLC · Radiology device
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May 2008
Decision
58d
Days
Class 2
Risk

K080762 is an FDA 510(k) clearance for the IB NEURO, VERSION 1.0. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Imaging Biometrics, LLC (Elm Grove, US). The FDA issued a Cleared decision on May 15, 2008 after a review of 58 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 Imaging Biometrics, LLC devices

Submission Details

510(k) Number K080762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2008
Decision Date May 15, 2008
Days to Decision 58 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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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