đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an MRI surface coil for obtaining diagnostic images of the temporomandibular joint.
- Use to improve signal reception and image quality when imaging the TMJ.
- Use in patients undergoing MRI evaluation for suspected temporomandibular joint pathology.
Clinical Applications
- MRI imaging of the temporomandibular joint.
- Evaluation of TMJ pain or dysfunction when MRI is clinically indicated.
- Assessment of TMJ structural abnormalities and joint integrity.
- Diagnostic imaging used to support treatment planning for TMJ disorders.
Practical Considerations
- The coil must be compatible with the MRI system, including the scanner interface, field strength, and available coil connections.
- Correct positioning over the jaw and appropriate immobilization are important for image quality and patient comfort.
- MRI safety screening is required for the patient and staff; ferromagnetic objects and other MRI-incompatible equipment must be kept outside the scan environment.
- The available FDA record does not specify coil dimensions, patient size ranges, or compatibility with particular MRI manufacturers; users should consult the device labeling and facility equipment documentation.
- The device is an imaging accessory, not a treatment for TMJ disease. MRI findings should be interpreted with the clinical examination and other diagnostic information.
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.