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model 2121-21 tmj surface coil
Medical Advances
Summary: The Model 2121-21 TMJ Surface Coil is an FDA-cleared device used for imaging the temporomandibular joint (TMJ) in MRI procedures. It is primarily used by radiologists and imaging specialists to enhance image quality and diagnostic accuracy.
FDA Clearance Information
Pathway
510K
Number
K901305 ↗
Decision Date
April 26, 1990
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The Model 2121-21 TMJ Surface Coil was cleared through the FDA's 510(k) pathway on April 26, 1990. Manufactured by Medical Advances, it is classified as a Class 2 device under product code LNH.
What It Is
The Model 2121-21 TMJ Surface Coil is a specialized MRI coil designed to improve imaging of the temporomandibular joint. It employs a quadrature detection system with two interleaved coplanar resonators, which enhances signal-to-noise ratio and image clarity. This device is particularly useful in capturing detailed images of the TMJ, aiding in the diagnosis of joint disorders.
Clinical Applications
This device is commonly used in radiology departments for patients undergoing MRI scans of the temporomandibular joint. It is particularly beneficial in diagnosing TMJ disorders, which can affect jaw movement and cause pain. The coil is used in outpatient imaging centers and hospitals, primarily by radiologists and MRI technologists.
Indications for Use
The FDA indications suggest that this device is intended for use in MRI procedures focusing on the temporomandibular joint. It is suitable for patients with suspected TMJ disorders, providing enhanced imaging to support accurate diagnosis.
Practical Considerations
The Model 2121-21 TMJ Surface Coil is designed to be compatible with standard 1.5 T MRI machines. Clinicians should ensure proper positioning to maximize image quality. The coil's design allows for improved signal reception, which is crucial for detailed TMJ imaging.
Related Literature
The linked study from 1987 describes a surface coil assembly with two interleaved resonators used for imaging at 1.5 T. The study found that this design improved the signal-to-noise ratio by 2.5 times for TMJ images. However, the study's limitations include its focus on a specific imaging depth and the need for further validation in clinical settings.
Frequently Asked Questions
What is the Model 2121-21 TMJ Surface Coil used for?
It is used for enhancing MRI imaging of the temporomandibular joint, aiding in the diagnosis of TMJ disorders.
What specialties typically use this device?
Radiologists and MRI technologists in imaging centers and hospitals use this device for TMJ imaging.
What are the FDA-cleared indications?
The device is indicated for MRI procedures targeting the temporomandibular joint, particularly for diagnosing 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.