📋 FDA Reference
Hts Extremity Coil Hts Surface Coil
Time Medical Systems
Summary: The HTS Extremity Coil is a specialized MRI coil used to enhance imaging quality for extremities. It is primarily used by radiologists in imaging centers and hospitals.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K112293 ↗
Decision Date ?
September 30, 2011
Product Code ?
MOS
Device Class ?
Class 2
Evidence ?
0 studies
The HTS Extremity Coil by Time Medical Systems was cleared through the FDA 510(k) pathway on September 30, 2011. It is a Class 2 device under product code MOS.
What It Is
The HTS Extremity Coil is a high-temperature superconducting (HTS) surface coil designed for MRI imaging of extremities. It operates by enhancing the signal-to-noise ratio (SNR) compared to traditional copper coils, allowing for clearer and more detailed images. This improvement is particularly beneficial in low-field MRI settings.
FDA-Cleared Indications
- Use with compatible MRI systems to acquire diagnostic images of the extremities.
- Use as an MRI surface coil for imaging extremity anatomy.
Clinical Applications
- MRI of the upper extremities, including the shoulder, arm, elbow, forearm, wrist and hand.
- MRI of the lower extremities, including the hip, thigh, knee, lower leg, ankle and foot.
- Musculoskeletal MRI evaluation when a dedicated extremity coil is appropriate.
- Acquisition of diagnostic MRI images in hospitals and outpatient imaging facilities with compatible MRI equipment.
Practical Considerations
- Compatibility must be confirmed with the MRI scanner, operating field strength, receiver system and available coil interface before use.
- The coil is an MRI accessory and must be used according to the manufacturer's instructions for positioning, connection, inspection and operation.
- High-temperature superconducting coil systems may require specific cooling, power or support equipment.
- Patients and staff must follow standard MRI screening and safety procedures, including assessment for implants, metal objects and other MRI contraindications.
- Coil dimensions and positioning may limit imaging of larger extremities or patients whose anatomy does not fit within the available coil.
Related Literature
The linked study explored the use of HTS RF coils in clinical MRI imaging at low field strengths. It demonstrated that HTS coils provide a significant improvement in signal-to-noise ratio over traditional copper coils, enhancing image quality. However, the study was limited by its focus on small sample sizes and specific low-field conditions, which may not generalize to all clinical settings.
Frequently Asked Questions
What is the HTS Extremity Coil used for?
The HTS Extremity Coil is used for high-resolution MRI imaging of the extremities, improving image quality for diagnostic purposes.
What specialties typically use this device?
Radiologists and musculoskeletal specialists commonly use this device in imaging centers and hospitals.
What are the FDA-cleared indications?
The device is cleared for use in obtaining high-quality MRI images of the extremities, particularly useful for musculoskeletal conditions.
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.