Cleared Traditional

K140998 - PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL

K140998 is an FDA 510(k) clearance for PEDIATRIC 16, 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 84-day FDA review.

K140998 · Quality Electrodynamics, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
84d
Days
Class 2
Risk

K140998 is an FDA 510(k) clearance for the PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL. 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 July 11, 2014 after a review of 84 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.

FDA 510(k) Submission Details - K140998

510(k) Number K140998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2014
Decision Date July 11, 2014
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K140998.
BREAST SPEEDER CX, GRID HOLDER CX
K142002 · Quality Electrodynamics, LLC · Aug 2014
NORAS OR HEAD HOLDER FLEXIBILITY
K133506 · Noras Mri Products GmbH · Aug 2014
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE
K141832 · Neocoil, LLC · Jul 2014
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
K140606 · Resonance Innovations, LLC · May 2014
16 CH MULTIPURPOSE COIL VARIETY
K140252 · Noras Rontgen-Und Medizintechnik GmbH · May 2014
ST SENSE NV 8 ARRAY COIL
K140282 · Resonance Innovations, LLC · Feb 2014
K140998 · PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL
Download PDF FDA Summary Quality Electrodynami…