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model 8010 extremity surface coil
Medical Advances
Summary: The Model 8010 Extremity Surface Coil is a medical device used in MRI procedures to enhance imaging of extremities. It is primarily used by radiologists and technicians in hospital and imaging center settings.
FDA Clearance Information
Pathway
510K
Number
K901092 ↗
Decision Date
April 5, 1990
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The Model 8010 Extremity Surface Coil by Medical Advances was cleared through the FDA 510(k) pathway on April 5, 1990. It is classified as a Class 2 device under product code LNH.
What It Is
The Model 8010 Extremity Surface Coil is a specialized coil used in MRI machines to improve the quality of images of extremities such as arms and legs. It works by enhancing the signal-to-noise ratio in the targeted area, allowing for clearer and more detailed images. This device is crucial for accurately diagnosing conditions affecting the extremities.
Clinical Applications
This coil is commonly used in orthopedic and sports medicine to assess injuries and conditions affecting the bones, joints, and soft tissues of the extremities. It is also used in oncology for tumor detection and monitoring in limbs. Radiologists and MRI technicians typically use this device in hospital radiology departments and outpatient imaging centers.
Indications for Use
The FDA indications suggest that this coil is intended for use in MRI procedures to obtain detailed images of the extremities. It is suitable for patients needing detailed imaging of limbs, such as those with suspected fractures, ligament tears, or tumors.
Practical Considerations
The Model 8010 coil is designed to fit around the extremities, making it compatible with most MRI machines. Proper positioning and technique are essential to maximize image quality. It is important to ensure the coil is correctly sized and positioned for each patient to obtain optimal results.
Frequently Asked Questions
What is the Model 8010 Extremity Surface Coil used for?
It is used to enhance MRI imaging of extremities, providing clearer images for diagnosis.
What specialties typically use this device?
Radiologists and MRI technicians in orthopedic, sports medicine, and oncology settings.
What are the FDA-cleared indications?
It is indicated for use in MRI procedures to obtain detailed images of the extremities.
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.