Cleared Abbreviated

K113474 - 1.5T GEM FLEX COIL

K113474 is an FDA 510(k) clearance for 1.5T GEM FLEX COIL, manufactured by Neocoil, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Abbreviated 510(k) pathway after a 115-day FDA review.

K113474 · Neocoil, LLC · Radiology device
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Mar 2012
Decision
115d
Days
Class 2
Risk

K113474 is an FDA 510(k) clearance for the 1.5T GEM FLEX COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Neocoil, LLC (Pewaukee, US). The FDA issued a Cleared decision on March 16, 2012 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Neocoil, LLC devices

FDA 510(k) Submission Details - K113474

510(k) Number K113474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2011
Decision Date March 16, 2012
Days to Decision 115 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Standards-based clearance path.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
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 - MOS Coil, Magnetic Resonance, Specialty

All 313
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K113474.
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646
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K122646 · Invivo Corporation · Nov 2012
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TEMPOROMANIBULAR COIL 15
K110373 · Esaote, S.P.A. · Apr 2011