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model 2121-64 tmj surface coil
Medical Advances
Summary: The Model 2121-64 TMJ Surface Coil is a specialized MRI coil used for imaging the temporomandibular joint (TMJ). It is primarily used by radiologists and dental specialists to obtain high-resolution images for diagnostic purposes.
FDA Clearance Information
Pathway
510K
Number
K901242 ↗
Decision Date
April 26, 1990
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The Model 2121-64 TMJ Surface Coil was cleared through the FDA 510(k) pathway on April 26, 1990. Manufactured by Medical Advances, it is classified as a Class 2 device under the product code LNH.
What It Is
The Model 2121-64 TMJ Surface Coil is a specialized MRI coil designed to improve the imaging quality of the temporomandibular joint. It uses a quadrature detection system with two interleaved coplanar resonators to enhance signal-to-noise ratio, providing clearer and more detailed images. This device is particularly useful in diagnosing TMJ disorders, allowing for precise visualization of joint structures.
Clinical Applications
This device is commonly used in radiology departments and dental clinics for patients with suspected TMJ disorders. It is particularly valuable in settings where detailed imaging of the TMJ is required, such as in pre-surgical planning or evaluating the extent of joint damage in chronic conditions. The coil is used primarily in adult populations but can be adapted for pediatric use with appropriate considerations.
Indications for Use
The FDA indications suggest that this device is intended for imaging the temporomandibular joint. It is suitable for patients experiencing jaw pain, dysfunction, or other symptoms indicative of TMJ disorders, providing detailed images that aid in diagnosis and treatment planning.
Practical Considerations
The Model 2121-64 TMJ Surface Coil is compatible with 1.5 T MRI systems. Clinicians should ensure proper positioning to maximize image quality. It is important to consider patient comfort and coil placement to avoid motion artifacts during imaging.
Related Literature
The linked study from 1987 describes a surface coil assembly with two interleaved coplanar resonators for imaging at 1.5 T. The study found that this configuration improved the signal-to-noise ratio by 2.5 times for TMJ images. However, the study was limited to a specific magnetic field strength and may not account for advancements in MRI technology since its publication.
Frequently Asked Questions
What is the Model 2121-64 TMJ Surface Coil used for?
It is used for obtaining high-resolution MRI images of the temporomandibular joint to aid in the diagnosis of TMJ disorders.
What specialties typically use this device?
Radiologists and dental specialists commonly use this device, particularly those focusing on TMJ disorders.
What are the FDA-cleared indications?
The device is indicated for imaging the temporomandibular joint, particularly in patients with symptoms of TMJ disorders.
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.