3.0T 16ch Breast Coil
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Neocoil, Llc
Identity
- Trade Name
- 3.0T 16ch Breast Coil EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 16ch Breast Coil EUDAMEDThe NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads. FDA UDI
- Model / Reference
- 16ch Breast Coil EUDAMEDM7006PA EUDAMED82 FDA UDI
- Description
- The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads. FDA UDI
Identifiers
- Catalog Number
- M7006PA FDA UDI
- Primary DI / UDI-DI
- 00856181003824 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850028932387S EUDAMED
- 510(k) Number
- FDA Product Code
- MOS FDA 510(k)FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The 3.0T 16-Channel Breast Coil is a phased array magnetic resonance coil designed for high-resolution imaging of breast tissue, axilla, and chest wall. It operates within a 3.0 Tesla MRI system and is classified as a specialty magnetic resonance coil, optimized for radiologic diagnostic applications.
This receive-only coil is modular, lightweight, and intended for single-use or reusable configurations (as specified by facility protocols). It requires MRI-compatible setup and is supplied sterile or non-sterile based on manufacturer instructions. Authorized under FDA 510K clearance and MDR, it adheres to Class II regulatory standards (892.1000) and is compatible with multiple registration numbers for traceability. Storage and handling follow standard MRI accessory protocols.
Frequently asked questions
What types of tissues can the 3.0T 16-Channel Breast Coil image, and how does its design support high-resolution imaging?
The coil is specifically designed for high-resolution imaging of breast tissue, the axilla (underarm region), and the chest wall. Its phased array configuration distributes multiple receiver channels across the coil, which enhances signal sensitivity and spatial resolution—critical for distinguishing fine details in soft tissues during MRI scans.
Is the coil reusable, and if so, what considerations should facilities keep in mind when deciding between single-use and reusable configurations?
The coil is designed for both single-use and reusable configurations, depending on facility protocols. Reusability requires adherence to strict cleaning, disinfection, and maintenance procedures to ensure MRI compatibility and signal integrity. Sterility is optional based on manufacturer instructions, so facilities must weigh cost, infection control policies, and coil performance degradation over repeated use.
How does the coil’s compatibility with MRI systems ensure safe and effective use, and what storage requirements apply?
The coil is explicitly designed for MRI-compatible use within a 3.0 Tesla system, meaning it adheres to electromagnetic safety standards to avoid interference or damage to the MRI environment. Storage should follow standard MRI accessory protocols—typically in a clean, dry environment away from magnetic fields or contaminants that could compromise its performance or sterility (if applicable).
What regulatory pathways does this coil follow, and how does that affect traceability for healthcare providers?
The coil is authorized under FDA 510(k) clearance and the EU MDR, classifying it as a Class II medical device (product code: MOS). Its traceability is supported by multiple registration numbers (e.g., 1058584, 3009529630) linked to OpenFDA, enabling healthcare providers to verify compliance, lot-specific details, and manufacturer accountability for recalls or updates.
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: Breast Coils - Chest MRI Coils - NeoCoil, PDF PRODUCT DATASHEET, 16CH BREAST COIL - neocoil.com, AccessGUDID - DEVICE: 3.0T 16ch Breast Coil (00856181003824)
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173377 | Class II | Active |
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Manufacturer
- Manufacturer
- Neocoil, Llc
Sources (3)
- FDA 510(k) K173377 24 fields · synced Sep 18, 2026
- FDA UDI a9a05baf-7f1d-4fbe-bb60-bc7200fc34e9 35 fields · synced May 30, 2026
- EUDAMED 31af7e61-8608-4928-8389-9c1eba23dd68 61 fields · synced Sep 17, 2026