Cleared Traditional

K061255 - BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0

K061255 is an FDA 510(k) clearance for BRAINACQUIRERX / BRAINPROCESSRX DATA SU..., manufactured by Kyron Clinical Imaging, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K061255 · Kyron Clinical Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
40d
Days
Class 2
Risk

K061255 is an FDA 510(k) clearance for the BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Kyron Clinical Imaging, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on June 13, 2006 after a review of 40 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 Kyron Clinical Imaging, Inc. devices

FDA 510(k) Submission Details - K061255

510(k) Number K061255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2006
Decision Date June 13, 2006
Days to Decision 40 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
67d faster than avg
Panel avg: 107d · This submission: 40d
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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 912
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