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medrad phased array 1 5t shoulder imaging surface coil
Medrad
Summary: The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is a specialized MRI coil used for high-resolution imaging of the shoulder. It is primarily used by radiologists and orthopedic specialists to diagnose shoulder pathologies.
FDA Clearance Information
Pathway
510K
Number
K960901 ↗
Decision Date
May 29, 1996
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil was cleared through the FDA 510(k) pathway on May 29, 1996. It is manufactured by Medrad and is classified as a Class 2 device under product code LNH.
What It Is
This device is a specialized MRI coil designed to enhance the quality of shoulder imaging. By using phased array technology, it provides high-resolution images that are crucial for detailed assessment of shoulder anatomy and pathology. The coil is placed around the shoulder area and works by receiving radiofrequency signals during an MRI scan, allowing for improved image clarity and diagnostic accuracy.
Clinical Applications
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is commonly used in radiology departments for patients with suspected shoulder injuries or conditions such as rotator cuff tears, labral tears, and other soft tissue abnormalities. It is particularly valuable in pre-surgical planning and post-operative evaluations. Orthopedic specialists and sports medicine clinicians often rely on the detailed images provided by this coil to guide treatment decisions.
Indications for Use
The FDA indications suggest that this device is intended for use in imaging the shoulder region to diagnose various conditions. It is suitable for patients experiencing shoulder pain, limited mobility, or those with a history of shoulder trauma.
Practical Considerations
The coil is designed to fit comfortably around the shoulder, accommodating a range of patient sizes. It is compatible with 1.5T MRI systems and requires proper positioning to ensure optimal image quality. Clinicians should be familiar with MRI safety protocols when using this device.
Related Literature
The linked study investigated the use of contrast-enhanced Turbo-MRA (CE-MRA) for evaluating carotid artery stenosis. Although not directly related to the shoulder coil, it highlights the importance of advanced imaging techniques in vascular assessments. The study found CE-MRA to be feasible and accurate, though it focused on a different anatomical region and patient population.
Frequently Asked Questions
What is the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil used for?
It is used for high-resolution MRI imaging of the shoulder to diagnose conditions such as rotator cuff tears and labral tears.
What specialties typically use this device?
Radiologists and orthopedic specialists commonly use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for imaging the shoulder region to assist in diagnosing shoulder pathologies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.