Cleared Traditional

K142802 - Atlas SPEEDER Head/Neck

K142802 is an FDA 510(k) clearance for Atlas SPEEDER Head/Neck, manufactured by Quality Electrodynamics, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K142802 · Quality Electrodynamics, LLC · Radiology device
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Nov 2014
Decision
56d
Days
Class 2
Risk

K142802 is an FDA 510(k) clearance for the Atlas SPEEDER Head/Neck. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Quality Electrodynamics, LLC (Mayfield Village, US). The FDA issued a Cleared decision on November 24, 2014 after a review of 56 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 Quality Electrodynamics, LLC devices

FDA 510(k) Submission Details - K142802

510(k) Number K142802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2014
Decision Date November 24, 2014
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 328
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K142802.
16 ch Tx/Rx Knee SPEEDER
K151753 · Quality Electrodynamics, LLC · Aug 2015
Atlas SPEEDER Header/Neck
K151829 · Quality Electrodynamics, LLC · Jul 2015
18ch T/R Knee Coil
K150331 · Quality Electrodynamics, LLC · Apr 2015
BREAST SPEEDER CX, GRID HOLDER CX
K142002 · Quality Electrodynamics, LLC · Aug 2014
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
K140998 · Quality Electrodynamics, LLC · Jul 2014
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646
K122897 · Invivo Corporation · Dec 2012