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0.55T 12Ch Breast Coil

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260947

by Neocoil, Llc

Identifiers

510(k) Number
K260947 FDA 510(k)
FDA Product Code
MOS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 0.55T 12Ch Breast Coil is a Magnetic Resonance Imaging (MRI) RF receive-only coil designed for use with compatible 0.55T MRI systems. It is intended to enhance imaging of breast anatomy for diagnostic or interventional purposes.

The device is supplied as a single-use component and is regulated under FDA 510(k) clearance (K260947). It is classified as a Class 2 Radiology device with product code MOS and is cleared through the Special 510(k) pathway.

Frequently asked questions

Is this coil reusable or designed for single-use only, and what does that mean for my workflow?

The 0.55T 12Ch Breast Coil is explicitly designed for single-use only, meaning it is intended to be used once and then discarded. This eliminates the need for cleaning, sterilization, or reprocessing between patients, which can streamline workflows and reduce contamination risks in clinical settings.

What MRI systems is this coil compatible with, and how do I confirm compatibility?

This coil is specifically designed for use with compatible 0.55T MRI systems. While the exact models aren’t listed, compatibility is typically determined by the manufacturer’s documentation or technical specifications for their 0.55T systems. Always verify with your MRI vendor or NEOCOIL’s support team to ensure proper integration before use.

Are there different sizes or models available for this breast coil, or is it a one-size-fits-all design?

The provided data does not specify multiple sizes or models for the 0.55T 12Ch Breast Coil, implying it is likely a single configuration. However, coils can vary in fit based on patient anatomy, so clinical judgment and manufacturer guidelines should still be followed to ensure optimal imaging results.

How should I store this coil before use, and what are the shelf-life considerations?

Since the coil is single-use, storage instructions are typically provided in the packaging or manufacturer’s instructions. Generally, MRI coils should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve performance. The shelf-life isn’t explicitly stated here, but single-use medical devices like this are generally intended for immediate use upon opening, unless otherwise specified by NEOCOIL.

What regulatory pathway was used for FDA clearance, and does this affect how I should use or order the device?

The coil was cleared through the FDA’s Special 510(k) pathway, classified as a Class 2 Radiology device under product code MOS. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets safety and effectiveness standards. For ordering or use, this clearance confirms its compliance with U.S. regulations, but always follow the manufacturer’s instructions and your facility’s protocols for proper handling and integration with your MRI system.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 0.55T 12Ch Breast Coil (K260947) — FDA 510(k) | Innolitics, K260947 FDA 510 (k) - 0.55T 12Ch Breast Coil | Neocoil, LLC, 0.55T 12Ch Breast Coil | FDA Radiology AI Device

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Neocoil, Llc

Sources (1)

  • FDA 510(k) K260947 24 fields · synced Sep 19, 2026