Cleared Traditional

K182958 - 1.5T 16ch Breast Coil

K182958 is an FDA 510(k) clearance for 1.5T 16ch Breast Coil, manufactured by Neocoil, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K182958 · Neocoil, LLC · Radiology device
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Nov 2018
Decision
23d
Days
Class 2
Risk

K182958 is an FDA 510(k) clearance for the 1.5T 16ch Breast 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 November 16, 2018 after a review of 23 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 Neocoil, LLC devices

FDA 510(k) Submission Details - K182958

510(k) Number K182958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2018
Decision Date November 16, 2018
Days to Decision 23 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
84d faster than avg
Panel avg: 107d · This submission: 23d
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 312
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K182958.
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
Contour 24
K183111 · Quality Electrodynamics, LLC · Dec 2018
1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
K181948 · Rapid Biomedical GmbH · 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
3.0T Air MP M, 3.0T Air MP L
K182504 · Ge Healthcare Coils (Usa Instruments, Inc.) · Oct 2018
16ch Foot/ Ankle SPEEDER
K181697 · Quality Electrodynamics, LLC · Jul 2018