The XENOVIEW 3.0T Chest Coil is a flexible MRI coil designed to work with 3.0T MRI scanners. It is intended for use with hyperpolarized xenon gas inhaled by patients to provide detailed MRI images of lung ventilation. This device helps clinicians evaluate lung function in adult and pediatric patients, enhancing pulmonary imaging capabilities with advanced MRI technology.
The Polarean XENOVIEW 3.0T Chest Coil is to be used in conjunction with compatible 3.0T Magnetic Resonance Imaging (MRI) scanners and approved xenon Xe 129 hyperpolarized for oral inhalation for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
The device is a flexible, single channel transmit-receive RF coil tuned to the 129Xe frequency on a 3.0T MRI magnetic field for imaging hyperpolarized 129Xe nuclei. The coil includes durable circuitry enclosed in non-conductive, flame-rated materials with padding for patient comfort, and uses fixed matching and tuning to eliminate the need for operator tuning.
Non-clinical bench testing was conducted including performance testing per NEMA and IEC standards for signal-to-noise ratio, specific absorption rate, RF coil heating, electrical safety, EMC, and biocompatibility per ISO standards. No clinical testing was required to demonstrate substantial equivalence. Testing confirmed the device is as safe and effective as its predicate device.
No predicate devices specified
Submission
10/22/2024
FDA Approval
11/19/2024
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