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model 2030 3 tmj surface coil
Medical Advances
Summary: The Model 2030 3 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 assess TMJ disorders.
FDA Clearance Information
Pathway
510K
Number
K891598 ↗
Decision Date
May 11, 1989
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The Model 2030 3 TMJ Surface Coil was cleared through the FDA 510(k) pathway on May 11, 1989. Manufactured by Medical Advances, it is classified as a Class 2 device under product code LNH.
What It Is
The Model 2030 3 TMJ Surface Coil is a specialized MRI coil designed to enhance the imaging of the temporomandibular joint (TMJ). It works by providing a focused magnetic field that improves the resolution and clarity of TMJ images. This device is crucial for diagnosing and evaluating TMJ disorders, offering detailed views of joint structures.
Clinical Applications
This device is commonly used in radiology departments and dental clinics for patients experiencing TMJ pain or dysfunction. It is particularly valuable in assessing conditions such as TMJ arthritis, dislocation, and other joint abnormalities. Radiologists and dental specialists rely on this coil for precise imaging in both outpatient and hospital settings.
Indications for Use
The FDA-cleared indications for this device include imaging of the temporomandibular joint to diagnose and evaluate TMJ disorders. It is intended for patients with symptoms such as jaw pain, clicking, or limited movement.
Practical Considerations
The Model 2030 3 TMJ Surface Coil is typically compatible with standard MRI machines. Clinicians should ensure proper positioning to optimize image quality. It is important to verify compatibility with the specific MRI system in use.
Frequently Asked Questions
What is the Model 2030 3 TMJ Surface Coil used for?
It is used for high-resolution MRI imaging of the temporomandibular joint to diagnose and evaluate TMJ disorders.
What specialties typically use this device?
Radiologists and dental specialists commonly use this device for TMJ imaging.
What are the FDA-cleared indications?
The device is indicated for imaging the temporomandibular joint to assess TMJ disorders in patients with symptoms like jaw pain or limited movement.
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.