📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- MRI imaging of the temporomandibular joint.
- Evaluation of TMJ disorders and abnormalities.
Clinical Applications
- MRI evaluation of the TMJ in patients with jaw pain or dysfunction.
- Imaging of TMJ joint structures when arthritis or other abnormalities are suspected.
- Evaluation of suspected TMJ dislocation or altered joint position.
- Assessment of patients with jaw clicking or limited mandibular movement.
Practical Considerations
- Compatibility must be confirmed with the specific MRI scanner, field strength, connectors, and system interface.
- The coil requires careful positioning over the TMJ to obtain diagnostic images.
- MRI safety screening is required for the patient and for any equipment used near the scanner.
- The coil should be inspected for cable, housing, connector, and padding damage before use.
- MRI contraindications and precautions, including certain implants, foreign bodies, and monitoring devices, apply to the patient; the device labeling should be checked for scanner-specific restrictions.
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.