Cleared Traditional

K183111 - Contour 24

K183111 is the FDA 510(k) clearance for Contour 24 by Quality Electrodynamics, LLC. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K183111 · Quality Electrodynamics, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
29d
Days
Class 2
Risk

K183111 is an FDA 510(k) clearance for the Contour 24. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Quality Electrodynamics, LLC (Mayfield Heights, US). The FDA issued a Cleared decision on December 7, 2018 after a review of 29 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

Submission Details

510(k) Number K183111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2018
Decision Date December 07, 2018
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 298
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K183111.
Encompass 15 Channel Head Coil, 3T
K190668 · Qfix · Sep 2019
3T 32 Channel Head Coil
K182737 · Nova Medical, Inc. · Apr 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24
K183186 · Shanghai United Imaging Healthcare Co., Ltd. · Feb 2019
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
K181948 · Rapid Biomedical GmbH · Nov 2018
1.5T 16ch Breast Coil
K182958 · Neocoil, LLC · Nov 2018
1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
K182590 · Ge Healthcare · Oct 2018