1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Neocoil, Llc
Identifiers
- 510(k) Number
- K201101 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 1.5T 16-Channel Shoulder Coil and 3.0T 16-Channel Shoulder Coil are receive-only phased array radiofrequency (RF) coils designed for magnetic resonance imaging (MRI). These coils are classified as Coil, Magnetic Resonance, Specialty and are optimized to enhance signal-to-noise ratio (SNR) for detailed visualization of shoulder anatomy, including the humerus, humeral head, labrum, glenoid, scapula, clavicle, and rotator cuff regions.
These coils are intended for use with 1.5T and 3.0T MRI systems and are supplied as reusable medical devices. They are regulated under FDA 510(k) clearance and MDR compliance, with a classification as Class II devices. Storage and handling follow standard MRI coil protocols to maintain performance and sterility where applicable. The coils are designed exclusively for MRI applications and must be used in accordance with manufacturer instructions.
Frequently asked questions
Are these coils designed for single-use or can they be reused, and what are the recommended handling procedures?
These coils are explicitly designed as reusable medical devices. To maintain performance and ensure longevity, they must be handled according to standard MRI coil protocols, which typically include cleaning, storage, and periodic inspection as outlined by the manufacturer’s instructions. Proper care is essential to preserve functionality and avoid contamination.
What MRI field strengths are compatible with these coils, and how do they improve imaging quality?
The coils are designed for use with both 1.5T and 3.0T MRI systems. They are 16-channel phased array receive-only coils optimized to enhance the signal-to-noise ratio (SNR), providing clearer and more detailed visualization of shoulder anatomy, including structures like the humerus, rotator cuff, and labrum.
How are these coils regulated, and what classification do they fall under?
These coils are classified as Class II medical devices under FDA regulations and have received 510(k) clearance, demonstrating substantial equivalence to predicate devices. They also comply with the EU Medical Device Regulation (MDR). The regulatory route confirms their safety and performance for intended MRI applications.
What specific anatomical regions do these coils focus on, and why is a 16-channel design beneficial?
The coils are specialized for detailed imaging of the shoulder anatomy, including the humerus, humeral head, labrum, glenoid, scapula, clavicle, and rotator cuff. A 16-channel design improves signal reception from multiple areas simultaneously, reducing scan time and enhancing resolution for better diagnostic clarity.
Are there any special storage requirements for these coils to maintain their performance?
While the data does not specify exact storage conditions beyond standard MRI coil protocols, reusable coils like these typically require protection from physical damage, electrostatic discharge, and environmental contaminants. Following manufacturer guidelines ensures optimal performance and longevity, particularly in clinical settings where they may be exposed to frequent use.
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: Shoulder Coils - 1.5T & 3T - NeoCoil, PDF PRODUCT DATASHEET, 16CH SHOULDER COIL - neocoil.com, 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil (K201101) — FDA 510 (k ...
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 | K201101 | Class II | Active |
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Manufacturer
- Manufacturer
- Neocoil, Llc
Sources (2)
- FDA 510(k) K201101 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026