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flexicoil - malleable receive-only surface coil
Odin Medical Technologies
Summary: The flexicoil is a malleable receive-only surface coil used in MRI procedures to enhance imaging quality. It is primarily used by radiologists and clinicians in imaging centers and hospitals.
FDA Clearance Information
Pathway
510K
Number
K020601 ↗
Decision Date
April 24, 2002
Product Code
MOS
Device Class
Class 2
Evidence
0 studies
The flexicoil was cleared through the FDA 510(k) pathway on April 24, 2002, by Odin Medical Technologies. It is classified as a Class 2 medical device under product code MOS.
What It Is
The flexicoil is a specialized surface coil designed to receive MRI signals, improving the quality and resolution of images. Its malleable design allows it to conform to various body parts, optimizing signal capture and enhancing diagnostic capabilities. This device is particularly useful in obtaining detailed images of soft tissues and is an essential tool in MRI suites.
Clinical Applications
The flexicoil is commonly used in MRI procedures to improve image quality, especially in complex anatomical regions. It is frequently employed in oncology for tumor imaging, aiding in both diagnosis and treatment planning. Radiologists and MRI technologists use this device in hospital radiology departments and specialized imaging centers, catering to a wide range of patients requiring detailed soft tissue imaging.
Indications for Use
The FDA indicates the flexicoil for use in enhancing MRI imaging, particularly useful in tumor ablation procedures. It is designed for patients needing precise imaging of soft tissues, aiding in accurate diagnosis and treatment planning.
Practical Considerations
The flexicoil is available in various sizes to accommodate different anatomical regions, ensuring optimal fit and signal reception. It is compatible with most MRI machines, but clinicians should verify compatibility with their specific equipment. Proper positioning and technique are crucial for maximizing image quality.
Frequently Asked Questions
What is flexicoil used for?
The flexicoil is used to enhance MRI imaging quality, particularly for detailed soft tissue visualization.
What specialties typically use this device?
Radiologists and MRI technologists in imaging centers and hospitals typically use the flexicoil.
What are the FDA-cleared indications?
The flexicoil is indicated for use in MRI procedures to improve imaging quality, especially in tumor ablation contexts.
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.