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model 2031 tmj surface coil
Medical Advances
Summary: The Model 2031 TMJ Surface Coil is an MRI accessory used to enhance imaging of 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
K895131 ↗
Decision Date
October 27, 1989
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The Model 2031 TMJ Surface Coil was cleared through the FDA 510(k) pathway on October 27, 1989. It is manufactured by Medical Advances and is classified as a Class 2 device under product code LNH.
What It Is
The Model 2031 TMJ Surface Coil is a specialized MRI coil designed to improve the quality of images of the temporomandibular joint (TMJ). By focusing on the TMJ area, it provides enhanced signal reception, resulting in clearer and more detailed images. This device is particularly useful in diagnosing TMJ disorders, which can include issues such as joint pain, dysfunction, and structural abnormalities.
Clinical Applications
This coil is commonly used in radiology departments and dental imaging centers. It is particularly beneficial for patients experiencing TMJ pain or dysfunction, allowing for precise imaging that aids in the diagnosis and treatment planning of TMJ disorders. Radiologists and oral surgeons frequently utilize this device to assess joint integrity and pathology in both adult and pediatric populations.
Indications for Use
The FDA indications suggest that this device is intended for use in obtaining detailed MRI images of the temporomandibular joint. It is suitable for patients with suspected TMJ disorders, including those with pain, limited movement, or structural concerns.
Practical Considerations
The Model 2031 TMJ Surface Coil is typically compatible with standard MRI machines. It is designed to fit comfortably around the patient's jaw area, ensuring optimal image quality. Clinicians should ensure proper positioning and calibration to achieve the best results.
Frequently Asked Questions
What is the Model 2031 TMJ Surface Coil used for?
It is used to obtain high-resolution MRI images of the temporomandibular joint, aiding in the diagnosis of TMJ disorders.
What specialties typically use this device?
Radiologists and dental specialists, particularly those focusing on oral and maxillofacial imaging, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for enhancing MRI imaging of the temporomandibular joint, particularly in patients with suspected 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.