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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
510K
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.
Clinical Applications
Commonly used in scenarios requiring detailed imaging of metabolic processes, such as assessing oxidative phosphorylation and mitochondrial function in tissues. It is particularly useful in research and clinical trials involving muscle and brain metabolism.
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.
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.