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31p 1h Dual Tuned Surface Coil 3t 23na 1h Dual Turned Surface Coil 3t 13c 1h Dual Turned Surface Coil 3t
Rapid Biomedical
Summary: The 31p 1h dual tuned surface coil 3T by Rapid Biomedical is a medical imaging device used primarily for magnetic resonance spectroscopic imaging (MRSI) to enhance imaging efficiency. Key evidence highlights its improved B1 efficiency and performance in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K102348 ↗
Decision Date ?
December 22, 2010
Product Code ?
MOS
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on December 22, 2010. It is manufactured by Rapid Biomedical and classified as a Class 2 device under product code MOS.
What It Is
The 31p 1h dual tuned surface coil 3T is designed for magnetic resonance spectroscopic imaging (MRSI), enhancing imaging efficiency for phosphorus (31P) and proton (1H) nuclei. It is intended for use in clinical settings to improve diagnostic imaging quality.
FDA-Cleared Indications
- For use with compatible 3-tesla MRI systems to acquire magnetic resonance signals from phosphorus-31 and hydrogen-1 nuclei.
- For magnetic resonance spectroscopy and magnetic resonance spectroscopic imaging of anatomy that can be positioned within the surface coil.
- The FDA record identifies the device under product code MOS as a Class II MRI accessory.
Clinical Applications
- Phosphorus-31 and proton magnetic resonance spectroscopy at 3 tesla.
- Magnetic resonance spectroscopic imaging of accessible tissues, such as skeletal muscle or the brain, when appropriate for the coil design.
- Acquisition of complementary phosphorus and proton MRI or spectroscopy data during a compatible clinical or research MRI examination.
Reported off-label uses
- Research evaluation of tissue energy metabolism, oxidative phosphorylation, or mitochondrial function using phosphorus-31 spectroscopy.
- Metabolic imaging studies of skeletal muscle or brain tissue in clinical research protocols.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 12 studies, comprising various study types such as RCTs and case series, conducted between 2021 and 2026. These studies explore the device's efficacy in enhancing imaging performance and its integration with other diagnostic modalities.
Reported Outcomes
Published studies report significant improvements in B1 efficiency for 31P and enhanced performance for 1H imaging. The device has been shown to improve the accuracy of metabolic assessments, such as oxidative phosphorylation, and is effective in integrating with other imaging techniques.
Safety Profile
Reported complications include technical challenges in achieving optimal resonance at 3T, which may affect imaging quality. However, no significant adverse events have been documented in the available studies.
Evidence Limitations
Evidence gaps include a need for larger-scale studies to confirm findings and explore long-term safety. Some studies report technical challenges that require further research to optimize device performance.
Practical Considerations
- This is a surface coil, so image and spectroscopy sensitivity is greatest near the coil and decreases with depth.
- It is intended for compatible 3-tesla MRI systems; the scanner, coil connector, and operating software must be compatible before use.
- The device is dual tuned for phosphorus-31 and hydrogen-1; it should be used according to the manufacturer’s instructions for positioning, tuning, loading, and setup.
- MRI safety depends on the specific coil model, scanner configuration, accessories, and operating conditions. Follow the manufacturer’s MR labeling and institutional MRI screening procedures.
- Patients with implanted or external devices, ferromagnetic objects, or other MRI contraindications require standard MRI safety evaluation before scanning.
Frequently Asked Questions
What are the clinical indications for 31p 1h dual tuned surface coil 3T?
The device is indicated for use in magnetic resonance spectroscopic imaging to enhance imaging efficiency for metabolic assessments, particularly in muscle and brain tissues.
What outcomes have been reported in clinical studies?
Studies have reported improvements in B1 efficiency and imaging performance, particularly for assessing oxidative phosphorylation and integrating with other imaging modalities.
What complications have been reported?
Reported complications include technical challenges in achieving optimal resonance at 3T, but no significant adverse events have been documented.
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.