← Back to catalogue

1.5T and 3.0T 16 CH GE Shoulder Coils

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162001

by Invivo Corporation

Identifiers

510(k) Number
K162001 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 and 3.0T 16-Channel GE Shoulder Coils are specialty magnetic resonance (MR) coils designed for high-resolution imaging of shoulder anatomy. These receive-only phased array coils optimize signal-to-noise ratio (SNR) and provide uniform coverage of critical structures, including the humerus, humeral head, labrum, glenoid, scapula, clavicle, and rotator cuff regions.

Intended for use in MRI systems operating at 1.5T and 3.0T field strengths, these coils are supplied as reusable medical devices. They are classified as Class II devices under FDA regulations (892.1000) and have received FDA 510(k) clearance (K162001) via a traditional review process. The coils are manufactured by Invivo Corporation and are regulated under the Radiology specialty category.

Frequently asked questions

Are these coils compatible with both 1.5T and 3.0T MRI systems, and how does that affect image quality?

Yes, these coils are explicitly designed for use with both 1.5T and 3.0T MRI systems, as stated in the description. They are receive-only phased array coils optimized to enhance the signal-to-noise ratio (SNR) and provide uniform coverage of shoulder anatomy, including critical structures like the humerus, rotator cuff, and labrum. The phased array design ensures consistent performance across these field strengths, improving diagnostic clarity for shoulder imaging.

How are these coils supplied, and are they intended for single-use or reusable applications?

The coils are supplied as reusable medical devices, as clearly noted in the description. They are not intended for single-use, which allows for cost-effective use in clinical settings while maintaining high performance for repeated shoulder MRI scans.

What specific shoulder anatomy regions do these coils focus on, and why is that important for imaging?

These coils are designed to provide high-resolution imaging of critical shoulder structures, including the humerus, humeral head, labrum, glenoid, scapula, clavicle, and rotator cuff regions. This focused coverage is important because it ensures detailed visualization of areas commonly affected by injuries or degenerative conditions, improving diagnostic accuracy for conditions like rotator cuff tears, labral injuries, or arthritis.

What regulatory pathway was followed for FDA clearance, and what does that mean for clinical adoption?

The coils received FDA 510(k) clearance (K162001) through a traditional review process, as stated in the data. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards. Clinically, this clearance indicates that the coils have undergone rigorous evaluation by the FDA’s Radiology advisory committee, supporting their reliability for shoulder MRI imaging in accredited facilities.

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: 1.5T and 3.0T 16 CH GE Shoulder Coils (K162001) — FDA 510(k ..., MRI - 1.5T 16ch Shoulder Coil with Cable 5720376-2 - GE Healthcare, Shoulder Coils - 1.5T & 3T - NeoCoil

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Invivo Corporation

Sources (1)

  • FDA 510(k) K162001 24 fields · synced Sep 18, 2026