đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a receive-only surface coil during MRI examinations.
- Enhance MRI signal reception and image quality for diagnostic imaging.
- Support imaging of anatomical regions that can be positioned beneath or adjacent to the coil.
Clinical Applications
- MRI examination of soft-tissue anatomy.
- MRI imaging when improved local signal reception is needed.
- Imaging of body regions requiring a conformable surface coil.
Practical Considerations
- Confirm compatibility with the specific MRI system, field strength, connectors, and operating conditions before use.
- The coil is receive-only and does not replace the MRI system's transmit function.
- Position the coil close to the anatomy of interest without compromising patient comfort, ventilation, or safe access.
- Follow the manufacturer’s instructions for cleaning, handling, positioning, and inspection for damage.
- Screen patients according to standard MRI safety procedures, including assessment of implants, metallic objects, and other contraindications.
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.