Cleared Traditional

K091114 - TXRX 1.5T CP HEAD COIL

Also marketed or referenced as:
TXRX 3T CP HEAD COIL

K091114 is an FDA 510(k) clearance for TXRX 1.5T CP HEAD COIL, manufactured by Quality Electrodynamics. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K091114 · Quality Electrodynamics · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
14d
Days
Class 2
Risk

K091114 is an FDA 510(k) clearance for the TXRX 1.5T CP HEAD COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Quality Electrodynamics (Mayfield Village, US). The FDA issued a Cleared decision on May 1, 2009 after a review of 14 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 devices

FDA 510(k) Submission Details - K091114

510(k) Number K091114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2009
Decision Date May 01, 2009
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K091114.
S-SCAN, MODEL 9800020010
K100670 · Esaote, S.P.A. · Apr 2010
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
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1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL
K093284 · Invivo Corporation · Feb 2010
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166 · Siemens Medical Solutions USA, Inc. · Jan 2009
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
K083086 · Hitachi Medical Systems America, Inc. · Dec 2008
ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
K083014 · Toshiba America Medical Systems, In.C · Oct 2008